Clinical trial NCT03727061
Conditions: Recurrent Head and Neck Carcinoma Locally Advanced Head and Neck Carcinoma
Sponsor: Roswell Park Cancer Institute
Start date: 2019-07-10; Completion date: 2024-10-22
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I trial studies the side effects of interstitial photodynamic therapy (I-PDT) in treating patients with head and neck cancer that has spread to other parts of the body or that has come back. Interstitial photodynamic therapy uses a light-sensitive drug called porfimer sodium. This drug is activated by laser light delivered through special fibers into the tumor.

In this study the doctors will evaluate the safety of I-PDT and determine the potentially effective light setting in this treatment.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the safety of porfimer sodium (Photofrin) mediated interstitial photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck cancer (HNC) .

* To determine the recommended light irradiance dose for a future Phase 2 trial of Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC

EXPLORATORY OBJECTIVES:

I . To access the objective tumor response rate

OUTLINE: This is a phase I study .

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes and undergo I-PDT approximately 48 hours later.

After completion of study treatment, patients are followed up every 1-3 months for the first year, 2-6 months for 2nd year, and annually up to 5 years.

Arms: arm 1: Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later.
Interventions: intervention 1: Nivolumab intervention 2: Porfimer Sodium intervention 3: Interstitial Illumination Photodynamic Therapy intervention 4: Quality of Life Assessment
Intervention descriptions: intervention 1: Immunotherapy - Standard of care intervention 2: Given IV intervention 3: Undergo I-PDT intervention 4: Ancillary Studies

Protocol documents:
Prot_SAP_001.pdf: 
Document Coversheet 
 
 Study Title: 
A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment of 
Patients with Locally Advanced or Recurrent Head and Neck Cancer 
 
Institution/Site:  
Roswell Park Comprehensive Cancer Center 
Document (Approval/Update) Date: 
03/13/2023 
NCT Number: 
NCT 03727061 
IRB Number 
I 67918 
 


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PROTOCOL TITLE:
A  Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment 
of Patients with Locally Advanced or Recurrent Head and Neck Cancer.
PROTOCOL NUMBER: 
I 67918
PRINCIPAL INVESTIGATOR:
Kimberly Wooten, MD
Roswell Park Comprehensive Cancer Center
Elm and Carlton Street
Buffalo, New York 14263
716-845-4094
Kimberly.Wooten@RoswellPark.org
VERSION NUMBER: 
8
DATE: 
13MAR2023
Confidentiality Statement
Any and all information presented in this document shall be treated as confidential and shall 
remain the exclusive property of the party(ies) mentioned above (Roswell Park Cancer Institute 
Corporation d/b/a Roswell Park Comprehensive Cancer Institute). The use of such confidential 
information must be restricted to the recipient for the agreed purpose and must not be disclosed, 
published, or otherwise communicated to any unauthorized persons, for any reason, in any form 
whatsoever without the prior written consent of the party(ies) above.
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Table of Contents
1.0
Objectives...............................................................................................................................5
2.0
Background ............................................................................................................................5
3.0
Inclusion and Exclusion Criteria..........................................................................................11
4.0
Local and Study-Wide Number of Subjects.........................................................................13
5.0
Local and Study-Wide Recruitment Methods......................................................................13
6.0
Multi-Site Research..............................................................................................................13
7.0
Study Timelines....................................................................................................................13
8.0
Study Endpoints ...................................................................................................................13
9.0
Study Design ........................................................................................................................13
10.0
Treatment .............................................................................................................................16
11.0
Procedures Involved.............................................................................................................20
12.0
Withdrawal of Subjects........................................................................................................25
13.0
Risks to Subjects ..................................................................................................................25
14.0
Potential Benefits to Subjects...............................................................................................26
15.0
Data and Specimen Banking ................................................................................................26
16.0
Measurement of Effect.........................................................................................................26
17.0
Safety Evaluation .................................................................................................................28
18.0
Data Management and Confidentiality ................................................................................33
19.0
Statistical Plan......................................................................................................................34
20.0
Provisions to Monitor the Data to Ensure the Safety of Subjects........................................36
21.0
Vulnerable Populations ........................................................................................................36
22.0
Community-Based Participatory Research ..........................................................................36
23.0
Sharing of Results with Subjects..........................................................................................36
24.0
Setting ..................................................................................................................................36
25.0
Provisions to Protect the Privacy Interests of Subjects........................................................36
26.0
Resources Available.............................................................................................................36
27.0
Prior Approvals ....................................................................................................................36
28.0
Compensation for Research-Related Injury.........................................................................36
29.0
Economic Burden to Subjects ..............................................................................................37
30.0
Consent Process....................................................................................................................37
31.0
Process to Document Consent in Writing ............................................................................37
32.0
Drugs or Devices..................................................................................................................38
33.0
References............................................................................................................................41
34.0
Appendices/ Supplements ....................................................................................................47
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1.0
Objectives
1.1
Primary Objectives

To determine the safety of porfimer sodium (Photofrin®) mediated interstitial 
photodynamic therapy (I-PDT) in patients with locally advanced or recurrent head and neck 
cancer (HNC).
o
To determine the recommended light irradiance dose for a future Phase 2 trial of 
Photofrin® mediated I-PDT in patients with locally advanced or recurrent HNC.
1.2
Exploratory Objectives 

To assess the objective tumor response rate.
2.0
Background
2.1
Locally Advanced Head and Neck Cancer and Current Treatment Approaches
Recent cancer statistics in the U.S. predicted that 51,540 men and women would be diagnosed with 
and 10,030 men and women would die of cancer of the oral cavity and pharynx in 2018.(1) These 
numbers represent an estimate increase of 21% and 19% in incidence and death rate, respectively, 
when compared to the published statistics in 2014 (i.e., 42,440 and 8,390 incidence and death rate, 
respectively).(2) These data (and statistics for 2015-2017, (3-5)) suggest that there is a constant 
increase in incidence and death rates for patients with HNC in the U.S. Although approximately 60–
65% of these patients can be cured with surgery, chemoradiation, and targeted therapy, the rest  will 
eventually die of local regional recurrent and/or metastatic disease. Among them, more than 40-60% 
of the patients will have persistent or recurrent local regional disease.(6) Locally advanced and 
recurrent head and neck squamous cell carcinoma (HNSCC) are frequently resistant (refractory) to 
standard chemotherapy and are typically not amenable to receive curative radiation therapy.(7-10) 
The newest immunotherapy regimens result in encouraging but limited overall response rate of no 
more than 16%.(11, 12) These aggressive tumors grow to destroy vital structures and patients often 
die from airway obstruction and uncontrolled local hemorrhage.(13) 
Quality of life and survival of these patients are severely compromised due to local effects of recurrent 
disease. Systemic chemotherapy is a widely used tool for reducing tumor burden, with the assumption 
that this leads to alleviation of tumor-related symptoms and prolongs survival. Platinum agent 
(cisplatin or carboplatin) and 5-FU have been considered the most effective first line chemotherapy 
for these patients. A phase III study (EXTREME study) has shown that the addition of Cetuximab can 
improve the response to 36% and the median survival from 7 to 10.3 months, in comparison to a 
regimen that includes only platinum and 5-FU.(10) This SoC therapy, however, is associated with 
extensive morbidity that relates to the use of the platinum agent and 5-FU, particularly. The potential 
adverse events include bone marrow suppression, neuropathy, ototoxicity, renal toxicity, mucositis, 
gastrointestinal and hematologic toxicities.(10) Furthermore, poor tolerability of the aforementioned 
chemotherapy regimen limits this approach to a relatively small number of patients that can receive 
this therapy. 
Salvage surgery has limited success that is associated with sever disfigurement and morbidity (13). 
Re-irradiation (Re-RT) with concurrent chemotherapy (Re-CTRT) has been suggested for selected 
patients with locally advanced, locoregional recurrent HNC in a previously irradiated field.(7) 
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Several groups have reported their retrospective experiences with Re-RT, and have suggested a 
feasibility and survival benefit of this approach.(14, 15) A phase III multi-institutional study 
conducted in France evaluated the efficacy of Re-CTRT after salvage surgery and demonstrated 
that deaths due to locoregional recurrence were less frequent in the Re-CTRT arm than in the wait 
and see (WS) arm.(16) However, treatment related deaths were more frequent in the Re-CTRT arm 
than in the WS arm.(16) Patients with severe toxicity, such as osteonecrosis and trismus from prior 
radiation have typically been excluded from reported experiences with Re-RT.(17) Therefore, Re-
RT is still considered experimental by many, and feasible only in a limited patient population.(17, 
18) 
2.2
Clinical Use of Porfimer Sodium (Photofrin®)
The U.S. Food and Drug Administration (FDA) approved the use of porfimer sodium mediated 
PDT for the treatment of esophageal cancer, NSCLC and High-Grade Dysplasia in Barrett’s 
Esophagus.(19, 20) In PDT, systemic administration of porfimer sodium is followed by 
illumination of the target tissue with visible light that leads to the generation of reactive oxygen 
species, notably singlet oxygen.(21) Porfimer sodium is being used off label and in clinical studies 
to treat many other cancers, including HNC.(22-27) These were retrospective studies in patients 
with early stage (T1, T2) HNSCC. Theses researchers reported complete response rates of 80-85%, 
suggesting that porfimer sodium mediated PDT can be effective in treating HNSCC. 
A detailed description of the specific indications and, discussion of the clinical pharmacology, 
pharmacokinetics, and toxicology of porfimer sodium can be found in the Photofrin® prescribing 
information (http://www.photofrin.com/wp-content/uploads/2013/02/prescribing-info.pdf).
2.3
Clinical Use of PDT with Chemotherapy
PDT with photosensitizers (PSs) in combination with chemotherapy has shown promising 
outcomes in down staging and improve local control, overall all survival and quality of life of 
patients with advanced non-small cell lung cancer (NSCLC).(28-30) The PDT was done pre or 
intraoperatively and in one study chemotherapy was administered on day of or day after PDT in 
patients with stage IIa to IV NSCLC.(28) (30)
Several retrospective studies suggested that Photofrin® mediated PDT with chemotherapy could 
improve the outcomes for patients with advanced esophageal cancer, and for patients with 
unresectable cholangiocarcinoma.(31-33) Photofrin® mediated PDT + chemotherapy has been 
reported to be better than either PDT alone or chemotherapy alone in the treatment of unresectable 
cholangiocarcinoma and advanced esophageal cancer in a limited number of studies.(31, 33, 34) A 
relatively large retrospective study by Lindenmann et al. (35) suggested that adding Photofrin® 
mediated PDT prior to standard of care (n=118) resulted in better overall survival than adding PDT 
after SoC (n=130) in patients with inoperable esophageal cancer. (35) That report was in agreement 
with Li et al. 2010(31) who found that Photofrin® mediated PDT before chemotherapy (n=33) is 
associated with significantly better overall response when compared with either Photofrin® 
mediated PDT (n=27) or chemotherapy alone (n=30) in patients with advanced esophageal 
cancer.(31) 
Importantly, the above-mentioned studies did not report of added toxicity or serious adverse events 
due to the combination of PDT and chemotherapy. 
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Our preliminary experience suggests that porfimer sodium mediated I-PDT with chemotherapy is 
safe and may hold promise for patients with locally advanced recurrent HNSCC.(36)
2.4
Preclinical Studies in Photofrin® Mediated I-PDT 
Ongoing NCI funded preclinical studies at Dr. Shafirstein’s laboratory (Shafirstein PI, 
RO1CA193610-03) focus on defining the impact of intratumoral light fluence rate (i.e., could also 
be referred to as irradiance) on response and cure of locally advanced tumors revealed that: 
1. Intratumoral light fluence rate appears to govern tumor response to I-PDT with Photofrin®. 
2. The clinically approved light intensity (400 mW/cm) for Photofrin® can impede photoreaction. 
Lower light intensities can be used to administer a safe and effective I-PDT in mice bearing 
syngeneic locally advanced squamous cell carcinomas (SCCVII), which is appropriate for 
studying treatments for HNC. (37, 38)
3. Intratumoral 630 ± 3nm laser light at a fluence rate of >8.6 mW/cm2 and a fluence of  >45 J/cm2 
delivered to 100% of the tumor volume will yield significantly (p<0.05, see Figure 1 below) 
high cure rate (70%-90%) in C3H mice bearing syngeneic 400-600 mm3 SCCVII tumors, a size 
of a locally advanced murine tumor. (39)
4. The finite element modeling (FEM) approach developed in Dr. Shafirstein laboratory (40, 41), 
and will be use in this study, can be used to compute intratumoral fluence rate and fluence for 
a range of laser settings to guide Photofrin® I-PDT in C3H mice bearing locally advanced 
SCCVII tumors and guide safe and potentially effective treatment in New Zealand White rabbits 
bearing large VX2 tumors in the neck (Figure 2).
Figure 1. Kaplan-Meier plots comparing response rate in C3H mice bearing locally advanced SCCVII treated 
with 630 ± 3nm laser light delivering >8.4 mW/cm2 and >45 J/cm2 to 100% of the tumor volume, at 0, 3.3, 5.0 
and 6.6 mg/kg Photofrin® dose. A significantly better response (p<0.05) was achieved for the I-PDT when 
compared to control and no drug. In this model cure was defined as complete regression of the tumor for at least 
60 days. Animals were euthanized at 60 days after treatment or when the tumor volume reached 4000 mm3. 
Therefore these data demonstrate that 70-90% cure was accomplished. (from Shafirstein et al. Journal British of 
Cancer, (2018) 119, 1191-1199)
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In previous publications we demonstrated that FEM could be used to plan and guide interstitial light 
delivery in models mimicking human tumors (40, 41). This modeling was used in a recent paper to 
guide I-PDT in the treatment of mice and NZW rabbits with VX2, part of the results are shown in 
figures 1 and 2 above. (Shafirstein et al. Journal British of Cancer, Accepted for publication July 5, 
2018).
We therefore propose to use the treatment planning to administer intratumoral 630 ± 3 nm laser 
light at >8.6 mW/cm2 and >45 J/cm2 to 100% of the tumor volume, as described in details in 
Section 10.2.
2.5
Study Rationale
There was a steady increase in incidence and disease related deaths for patients with HNC within 
the past 5 years in the US.(1-5) Patients die from locally advanced or recurrent HNC that have 
failed radiation therapy and have no viable treatment.(13, 42) Combination chemotherapy yields 
objective response rates of 10-36%.(8-10) Re-irradiation has been shown to be associated with 
significant toxicity.(16, 17, 42, 43) Salvage surgery is associated with prolonged hospitalization, 
and the cure rates are poor.(44, 45) These tumors are typically very heterogeneous, so theoretically 
their response to target therapy would be limited, and their response to immunotherapy (5-16%) is 
still being evaluated.(46)  
Several review papers and reports of retrospective studies suggested that adding PDT or I-PDT to 
SoC targeted and chemotherapy can improve OS and QoL in patients with unresectable 
cholangiocarcinoma, advanced esophageal cancer, lung cancer, malignant mesothelioma, and 
pancreatic cancer. (31, 33, 34, 47-49) Non-randomized, single-site, studies of I-PDT with 
Temoporfin have shown promising results in the treatment of patients with locally advanced and 
Figure 2. (A) Image of the rabbit treated with I-PDT. Visible in the image are the transparent close-end sharp catheters 
where treatment or dosimetry fibers were inserted. The blue probes are the optical thermometers that were placed on the 
tumor surface at margins. (B) 3-D representation of the treatment plan. The tumor is represented in blue. The intended 
treatment fibers are in green and the intended location of dosimetry fibers are in red. (C) 3-D representation of the 
intratumoral fluence rate throughout the tumor. (D) CT scan prior to treatment, and (E) a CT scan 41 days post treatment. 
(from Shafirstein et al. Journal British of Cancer, (2018) 119, 1191-1199)
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recurrent HNC that fail standard therapies.(50-52) However, I-PDT with Temoporfin is not 
approved for clinical use in the U.S. Photofrin® is the only clinically approved PS for treating 
cancerous tumors in the U.S.A. Our preliminary experience suggests that Photofrin® mediated I-
PDT may hold promise for patients with locally advanced and recurrent HNC. (36) While I-PDT 
has the potential to provide local control, it is acknowledged that patients with locally advanced 
disease require systematic therapy. And multiples studies suggest that adding PDT to the SoC 
chemotherapy is safe (as summarized in the above section 2.3). We hypothesize that Photofrin® 
mediated I-PDT will be a safe treatment in patients with locally advanced or recurrent head 
and neck cancer that failed radiation therapy. The goal of this study is to test the safety and find 
the recommended light irradiance for porfimer sodium mediated I-PDT in patients with locally 
advanced or recurrent HNC who are not candidates for standard or salvage surgery or radiotherapy. 
2.6
Correlative Studies
2.6.1
QUALITY OF LIFE EVALUATION
Several clinical studies suggested that PDT and I-PDT could improve QoL in patients with locally 
advanced HNC. (53-56) Few studies reported that I-PDT (with Temoporfin) reduced tumor related 
bleeding and pain, while improving breathing, speaking, swallowing, and appearance.(50, 51, 57) 
The impact of Photofrin® mediated I-PDT on QoL has not been evaluated, to date.
In this protocol, participants’ QoL will be evaluated with an accepted University of Washington 
Quality of Life Questionnaire Version 4 (UW-QoLQ v4: see Appendix E) (58, 59). It has been 
tested in several prospective studies and found to be reproducible, reliable, and valid for HNC 
patients: it is simple to complete, employs a simple algorithm to compute the overall score, and is 
easy to interpret while yielding objective results.(60) This version includes 12 individual Likert-
scale items and 4 global questions. Each participant’s overall score on the UW-QoLQ v4 will be 
calculated at baseline, at 12-16 weeks, and at 30 days post final treatment.
2.6.2
IMMUNE STUDIES (OPTIONAL)
In order to determine whether I-PDT enhances anti-tumor immunity a multi-pronged analysis will 
be performed. The effect of I-PDT on T cell activity will initially be determined by examining the 
activation status of participant T cells before and after I-PDT administration. PDT induces a rapid 
pro-inflammatory response and such responses are associated with T cell activation and 
proliferation, which are frequently muted in participants with advanced cancer. Furthermore, the 
effects of I-PDT on patient anti-tumor T cells are unknown. T cell activation will be determined by 
flow cytometric analysis of peripheral blood T cells. Using T cell subtype and activation specific 
profiles, this analysis will allow us to determine whether administration of I-PDT alters both the 
activation status and ratio of T cell subtypes present before and after therapy.
The phenotypic characterization described above will determine whether I-PDT affects T cell 
activation and subtype ratio but will not discern whether the effects are tumor specific. Most tumors 
over-express p53 and many head and neck tumors overexpress HPV 16. Examination of changes 
in the immune response to p53 and/or HPV16 can reveal changes in tumor specific immune 
responses. To examine whether PDT enhances the immune response to p53 or HPV 16, peripheral 
blood T cells will be isolated and exposed to p53 and HPV 16 ex vivo. The ability of each 
participant’s T cells to respond will be measured over time and compared against pre-treatment 
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results and to their ability to respond to antigens they have previously been exposed to, 
i.e., cytomegalovirus, Epstein-Barr virus and influenza virus (the so-called memory mix).
The third method for examining tumor specific T cells following I-PDT involves adding an 
additional marker to the flow panels described above. There is a well-defined p53 immune epitope 
that binds to the human major histocompatibility complex molecule HLAA2. Greater than 40% of 
the patients at Roswell Park express HLA-A2. HLA-A2 expression status of the trial participants 
will be determined. T cells isolated from HLA-A2+ participants will be tested for p53 reactivity 
using a flow cytometry reagent known as a tetramer that allows identification of p53 specific 
T cells.
Finally, we will examine changes in immune cell infiltrate and T cells activation status in tumors 
following PDT by comparing infiltrate and immune cell activation in tumors surgically removed 
from PDT treated patients to those removed non-PDT treated patients.
The mentioned immune studies analysis is optional for study participants with enough tissue for 
analysis as determined by the treating physician and dependent on amount of tumor, tumor location 
and if additional samples can be collected, which will vary based on the specifics of the tumor.
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3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
To be included in this study, participants must meet the following criteria:
1. Male or female patients age ≥ 18 years of age.
2. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status 
score of 0-2. Refer to Appendix A.
3.  Patients with locally advanced or recurrent head and neck cancer who failed to respond 
to standard therapy and are not amenable to standard curative treatment.
4. Tumor accessible for unrestricted illumination for interstitial Photodynamic Therapy 
(PDT) (accessibility as determined by the physician).
5. Life expectancy of at least 6 months, in the judgment of the physician.
6. Subjects of child-bearing potential must agree to use adequate contraceptive methods 
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 
the duration of study participation. Should a woman become pregnant or suspect she is 
pregnant while she or her partner is participating in this study, she should inform her 
treating physician immediately.
7. Subject must understand the investigational nature of this study and sign an Institutional 
Review Board approved written informed consent form prior to receiving any study 
related procedure.
Refer to Appendix B for the ELIGIBILITY VERIFICATION FORM: INCLUSION 
CRITERIA CHECKLIST.
3.2
Exclusion Criteria
Participants will be excluded from this study for the following:
1.  High dose curative radiotherapy within 30 days in the area to be treated.
2. Tumor invading a major blood vessel.
3. Tumor is not measurable on a CT or MRI scan according to RECIST v1.1.
4. Location and extension of the tumor precludes a potentially effective I-PDT.
5. Patients with known brain metastases should be excluded from this clinical trial because 
of their poor prognosis and because they often develop progressive neurologic 
dysfunction that would confound the evaluation of neurologic and other adverse events.
6. Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like 
compounds.
7. Platelet count < 75,000.
8. Patients with impaired renal and/or hepatic function (total serum bilirubin > 2 mg/dL, 
alkaline phosphatase (hepatic), SGOT or SGPT > 3 times the upper normal limit.
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9. Patients with moderately to severely impaired creatinine clearance (CrCl <44) will be 
excluded.
10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, 
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or 
psychiatric illness/social situations that would limit compliance with study requirements.
11. Pregnant or nursing female subjects.
12. Unwilling or unable to follow protocol requirements.
13. Any condition which in the Investigator’s opinion deems the subject an unsuitable 
candidate to receive porfimer sodium.
Refer to Appendix C for the ELIGIBILITY VERIFICATION FORM: EXCLUSION 
CRITERIA CHECKLIST.
3.3
Special Populations
The following special populations will be excluded from this study:

Cognitively impaired adults/adults with impaired decision-making 
capacity

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
3.4
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this study.
4.0
Local and Study-Wide Number of Subjects
In the Phase 1 study, a maximum of 12 (four cohorts of 3) evaluable participants at Roswell Park, 
will be enrolled. The number of subjects required is a function of the unknown dose-toxicity. 
5.0
Local and Study-Wide Recruitment Methods
Participants will be identified/recruited/screened from patients at the Head and Neck Clinic at 
Roswell Park and participating sites and from multi-disciplinary conference discussion.
6.0
Multi-Site Research
Not applicable-This is a single-site study.
7.0
Study Timelines
A maximum of 12 participants at Roswell Park will be enrolled. Accrual is expected to take 5 years, 
with follow-up for 24 months from the start of investigational treatment.
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8.0
Study Endpoints
8.1
Primary Endpoints

Phase 1:
o
The safety will be determined by recording the occurrence of AE during the 
first 30 days post final I-PDT day, using the revised NCI Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0. 
Exploratory Endpoint 
o
Objective target tumor response rates will be assessed according to RECIST v1.1 
at 12 ± 2 weeks post I-PDT as described in section 16.2. 
9.0
Study Design
All participants will meet the inclusion and exclusion criteria summarized in Section 3.1 and 
Section 3.2 prior to taking part in this study.
This study will recruit subjects with HNC who failed to respond to standard therapy and are not 
candidates for salvage surgery or radiation therapy including re-irradiation. These HNC subjects 
would otherwise receive SoC chemotherapy, targeted therapy or potentially immunotherapy as 
first line palliative care treatment options.
All participants will receive I-PDT. All participants will have a standard diagnostic head and neck 
scan with CT or MRI, with or without contrast. Participants will be followed according to the 
2018-NCCN follow-up guidelines (63; Appendix H) for patients with advanced HNC 
(https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf). The study related 
visits would be up to 2 years, thus every 1-3 months in the first year, and every 2-6 months in the 
second year. The routine clinical follow up will be up to 5 years. The study schema is shown in 
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Consent, Diagnosis and Staging
Adverse Events (AE)
Up to 30 days Post- Final I-PDT 
treatment
SOC: Objective tumor response at 10-12 weeks.  
Follow up for 24 months, post initial treatment. 
Routine Clinical Follow-up
According to 2018 NCCN follow-up Guidelines for advanced 
Head and Neck Cancer (Appendix H)
Phase 1 Study 
I-PDT + SoC in 3+3 Study Design
Primary Endpoint: Safety, at 30 days post final I-PDT treatment
.
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Figure 3 Study Schema
Consent, Diagnosis and Staging
Adverse Events (AE)
Up to 30 days Post- Final I-PDT 
treatment
SOC: Objective tumor response at 10-12 weeks.  
Follow up for 24 months, post initial treatment. 
Routine Clinical Follow-up
According to 2018 NCCN follow-up Guidelines for advanced 
Head and Neck Cancer (Appendix H)
Phase 1 Study 
I-PDT + SoC in 3+3 Study Design
Primary Endpoint: Safety, at 30 days post final I-PDT treatment
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10.0
Treatment
10.1
The Standard of Care Procedure
All participants will undergo a standard diagnostic head and neck scan with computed tomography 
(CT) or magnetic resonance imaging (MRI) as clinically indicated.
10.2
Interstitial Photodynamic Therapy (I-PDT)
10.2.1
Porfimer Sodium Administration
Subjects will receive a single intravenous dose of porfimer sodium that will be administered 
approximately 48 ± 8 hours before the first I-PDT treatment.
Drug administration will take place in a room that has covered windows to protect the subjects from 
light exposure that can induce phototoxicity (i.e., direct sun light or visible artificial light that is 
more than 60 W). The Principal Investigator or designee will inject the subjects with porfimer 
sodium for this study.
A dose of 2 mg/kg of porfimer sodium will be administered by slow intravenous injection into a 
vein (3-5 minutes). Light-avoidance measures for approximately 30-90 days will be required. The 
Clinical Research Coordinator and staff nurses will explain the light-avoidance measures to each 
subject and written instructions will be handed out to the subjects (Appendix F). The subject will 
be cautioned to protect the site of the infusion from excessive direct sunlight and certain bright 
lights for up to 3 months. The site may be exposed to normal ambient light.
Vital signs will be done immediately after the end of the injection and 15 minutes after.
10.2.2
Pre-treatment Planning
For all participants receiving I-PDT, a standard diagnostic head and neck scan with CT or MRI, 
will be obtained within 4 weeks prior to I-PDT. This imaging will be used for pre-treatment 
planning that will be conducted at Dr. Shafirstein’s laboratory at Roswell Park, with the treating 
physician at each participating site. 
The pretreatment planning will be carried out by following these steps:
1. If possible, clinically approved surface fiducial markers (using removal stickers) will be affixed 
to the skin (at the region of the tumor) prior to CT or MRI, to assist in the guidance of laser 
fibers, as described in Oakley et al. 2017(40). 
2. The scans will be de-identified, linked to a subject ID, and copied on CD or transferred via 
secure network to Dr. Shafirstein’s laboratory, 5-14 business days prior to the scheduled I-PDT. 
3. The treating physician will use the CT or MRI scans and the image reconstruction model for 
defining the clinical target volume (CTV). 
4. Image analysis software will be used to reconstruct the CT or MRI scans to generate a computer 
model of tumors and adjacent anatomy as we described in Oakley et al. 2015 and Oakley et 
al.2017.(40, 41) 
5. The treating physician will also use the computer model to recommend the number and location 
of closed-end transparent catheters that can be safely placed within the CTV. 
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6. The computer model (of the CTV) will be imported into a finite element modeling (FEM) 
software, to calculate the light intensity (mW/cm) and energy (J/cm) that will be required to be 
delivered by each fiber, so that 100% of the CTV receives the target light dose (i.e. computed 
fluence rate >8.6 mW/cm2 and fluence >45 J/cm2) as much as possible. 
7. The FEM simulations will be presented to the treating physician for approval of the treatment 
plan at least 5 business days prior to the I-PDT. 
Note: If subjects are scheduled to receive additional I-PDT courses (at least 30 days from the 
previous I-PDT, see Section 10.4), per the physician’s discretion, pre-treatment planning 
procedures for additional I-PDT courses are per the physician’s discretion.
10.2.3
I-PDT Procedure
The I-PDT will commence by following these steps:
1. An ultrasound system will be used, prior to fiber insertion, to confirm that the close-end 
sterile catheters can be safely placed into the CTV, according to the approved treatment 
plan. These catheters will be used to accommodate cylindrical laser fibers that will deliver 
the therapeutic light. If possible, an intraoperative CT (or other clinically approved 
radiological imaging) will be used to image the actual location of the inserted catheters. 
2. Laser fibers with cylindrical end will be inserted into the close-end sterile catheters, 
according to the approved treatment plan. Only one laser fiber will be inserted into each 
catheter. 
3. Additionally, dosimetry fibers to measure light will be inserted into other, nearby, close-end 
sterile catheters to monitor the light delivery.
4. The laser system(s) will be turned on to deliver the therapeutic light (630 ± 3 nm) into the 
tumor. 
5. A light dosimetry system (described in Section 32.2) will be used to monitor the light 
fluence rate, fluence and tumor during I-PDT, in all participating sites. 
The laser treatment and dosimetry fibers could be moved from one close-end sterile catheter to 
another to deliver the planned light fluence rate and fluence, and monitor the light and thermal dose. 
At any given time, there will be only one fiber (treatment or dosimetry) in a close-end sterile 
catheter. The laser fibers and detectors will not be in direct contact with patient tissue. Following 
administration of the laser light, the laser fibers and detectors will be removed, they will be cleaned 
and disinfected with an acceptable method (e.g., Cidex). The fibers and detectors can be reused, as 
they must be checked for calibration prior to each procedure.
Light Exposure Precautions
Light precautions will be maintained from the moment the subject enters the hospital and will 
continue while the subject is in the surgical suite and on the surgical subject care units. 
Subjects are instructed to wear their protective eyewear when they travel to the hospital. The 
surgery will be performed with room lights, which are modified by amber filters to minimize 
unwanted activation of the photosensitizing drug and inadvertent light exposure to the subjects. 
Yellow filter paper will be employed over the procedure room lights and the surgeons’ headlights 
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that blocks wavelength below 550 nm, thereby eliminating the light absorption by porphyrin in the 
UV and blue-green range. 
It has been the experience thus far that the surgeons have been able to adapt safely to operating with 
such filters in place. Incisions, if needed, will be shielded from inadvertent light exposure with 
sterile blue towels sewn or secured to the skin edges. The remainder of the subject’s skin will be 
draped in the usual surgical/sterile manner and therefore will not be inadvertently exposed to light 
during the entire procedure. The pulse-oximeter will be rotated between fingers every 15 minutes 
to avoid nail bed burns. Either disposable clips will be placed on all fingers, and the pulse-oximeter 
probe will be rotated or non-disposable clips will be rotated by the anesthesiologist.
These light precautions will be maintained throughout the entire hospital stay. Light precaution 
signs will be displayed above the subject’s bed at all times.
Appropriate goggles will be furnished and available for the surgeons and others to operate and 
function in the operating room when the laser light is on.
10.3
Definition of Dose-Limiting Toxicity
Dose Limiting Toxicities will include:
Any adverse events (AEs) that are ≥ grade 4 that are possibly, probably, or definitely related to the 
I-PDT, by recording the occurrence of AE during the first 30 days post final I-PDT treatment using 
the revised the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 
version 5.0 (CTCAE v5.0). Dose Limiting Toxicities will be evaluated for 30 days post final I-PDT 
day.
If participants experience DLTs, further I-PDT sessions will be held until DLT resolution as well 
as after porfimer sodium clearance.
10.4
Dose Escalation/Finding Schema
The FDA approved porfimer sodium dose (2 mg/kg) will not change. We will aim to deliver light 
fluence rate of ≥8.6 mW/cm2 and fluence of ≥45 J/cm2 to 100% of the CTV (dose level 1), as much 
as possible. Dose level -1 will ≥5.0 mW/cm2 and fluence of ≥45 J/cm2 to 100% of the CTV.
Table 2. The study plan for finding optimal fluence rate in I-PDT with Photofrin in patients with 
LAHNC.
Dose Level 
Number of 
patients with DLT 
at a given dose 
level
Decision rules
0 out of 3
Enter 3 patients at  Dose Level 1:
The laser fluence rate and fluence, scaled for human, 
which induced maximum photoreaction in the animal 
models
Dose Level 1 
(Starting):
The maximum 
fluence rate, 
scaled for 
human, which 
induced effective 
1 out of 3
Enter 3 more patients at this Dose Level .
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In participants where their tumors may require more than one course of I-PDT for complete 
effective illumination of the CTV, up to three sessions of I-PDT may be performed, at the discretion 
of the treating physician. The FDA approves to administer up to three courses of PDT with 
Photofrin® each separated by at least 30 days in the treatment of esophageal and endobronchial 
cancer (http://www.photofrin.com/wp-content/uploads/2013/02/prescribing-info.pdf.).  Therefore, 
treatment sessions in this study will be conducted at least 30-days apart. The porfimer sodium dose 
(2 mg/kg) will remain the same. 
See Appendix D 1 for the Dose Escalation Schedule of Events. The date of the last I-PDT course 
will be used to determine the scheduling of the follow up SoC related to this study. 
10.5
Treatment Discontinuation
All subjects who discontinue due to an AE must be followed until the event resolves or stabilizes. 
Appropriate medical care should be provided until signs and symptoms have abated, stabilized, or 
until abnormal laboratory findings have returned to acceptable or pre-study limits. The final status 
of the AE will be reported in the subject’s medical records and the appropriate eCRF.
Reasons for treatment discontinuation should be classified as follows:

Death

Progressive disease

Treatment-related toxicity

Toxicity unrelated to treatment

Investigator judgment

The Investigator may withdraw a subject if, in his/her judgment, it is in the subject’s best 
interest to do so.

Noncompliance

Subject voluntary withdrawal
o
A subject may withdraw from the study at any time, for any reason. If a subject 
discontinues treatment, an attempt should be made to obtain information regarding 
the reason for withdrawal.

Early withdrawal of subject(s)

Sponsor decision
Subjects who are unavailable for follow-up evaluations should be classified as lost to follow-up for 
1 of the following reasons:
≥ 2
Enter 3 patients at Dose Level -1:
The laser fluence rate and fluence, scaled for human, 
which induced minimal toxicity in the animal models.
photoreaction in 
the animal 
models.
≤ 1 out of 6
This is generally the recommended Phase II dose 
rate/dose. At least 6 patients must be entered at the 
recommended Phase II dose.
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
Lost to follow-up: For a subject to be considered lost to follow-up, the investigator must 
make two attempts to re-establish contact with the subject. The attempts to re-establish 
subject contact must be documented (e.g., certified letter).

Death: Date and cause of death will be recorded for those subjects who die within 30 days 
after treatment (telephone contact is acceptable).
11.0
Procedures Involved
11.1
Participant Registration
Eligibility of each participant will be established prior to enrollment. Patients at Roswell Park 
will be registered directly by Roswell staff using the web-based registration system. 
Informed consent MUST be completed prior to receiving any study related procedures.
11.2
Baseline Evaluations
The following will be performed within 8 weeks prior to administration of porfimer sodium:

Informed consent: Must be completed prior to receiving any study-related procedures

Medical history

Physical examination including vital signs (i.e., temperature, heart rate, respiratory rate, 
blood pressure, body weight, height, and pain assessment using a verbal score of 0 - 10) *

Hematology (i.e., complete blood count (CBC) with auto differential, absolute neutrophil 
count (ANC), and platelets) *, **

Chemistry (i.e., AST, ALT, total bilirubin, alkaline phosphatase, creatinine, potassium, 
glucose, and calcium) *

Pregnancy test (urine) in females of childbearing potential **

ECOG Performance Status **

UW QoLQ v4 #

Standard imaging for patients with HNC (i.e., CT and/or MRI) *, at least 10 business days 
prior to the scheduled I-PDT #

Pretreatment planning #

Concomitant Medications (including narcotic and nonnarcotic analgesics) **
*These are standard of care and may be used for baseline evaluation if performed before informed 
consent but within 4 weeks of porfimer sodium and can be used for the pretreatment planning.
**These will be done prior to later 2nd and 3rd later I-PDT sessions (if later I-PDT sessions are 
required per treating physician’s discretion per Section 10.4). Height does not need to be reassessed 
for later possible I-PDT sessions. If later I-PDT courses are deemed necessary, previous study 
treatment adverse events will be reviewed before the start of next I-PDT course.
# Performed as per PI discretion if 2nd and 3rd I-PDT courses are deemed necessary as per Section 
10.4.
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11.3
Pre-operative - Day of Porfimer Sodium Injection

48 ± 8 hours before illumination

Porfimer sodium solution (following the USPI) by a single slow intravenous injection over 
3-5 minutes at 2 mg/kg body weight 

Vital signs will be done immediately after the end of the injection and 15 minutes later
11.4
Evaluations Performed on the Day of Each I-PDT Treatment

ECOG Performance Status

Concomitant medication (including narcotic and nonnarcotic analgesics)

Adverse events

Pre-laser light research bloods (Optional) #

Intraoperative ultrasound #

Light dosimetry measurements 
# Performed per PI discretion if later I-PDT courses are deemed necessary as per Section 10.4.
11.5
Evaluations Performed at 1st Post-Operative Clinic Visit
This visit will be scheduled 1 to 4 weeks post I-PDT and will include:

Physical examination, including vital signs (i.e., temperature, heart rate, respiratory rate, 
blood pressure, body weight, and pain assessment using a verbal score of 0-10)

Hematology (i.e., CBC (with auto differential), ANC, and platelets)

Chemistry (i.e., AST, ALT, total bilirubin, alkaline phosphatase, creatinine, potassium, 
glucose, and calcium)

ECOG Performance Status

Adverse events

UW QoLQ v4

Research blood draws (Optional) #
# Performed as per PI discretion if later I-PDT courses are deemed necessary as per Section 10.4.
11.6
Post-Treatment Follow-Up
Follow-up safety evaluations will occur every 1-3 months during the first year and then every 2-
6 months in the second year after I-PDT day. 
Follow-up Clinic Visits
Participants will be followed according to the 2018-NCCN follow-up guidelines for patients with 
advanced HNC(63). The study related visits occur up to 2 years, thus every 1-3 months in the first 
year, and every 2-6 months in the second year. The efficacy will be determined at 10-12 weeks 
after the initial study related treatment (see Section 8.1).
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If it turns out that a participant will be scheduled to have a routine visit at 10-12 weeks (which 
is within 1-3 months), we will not schedule another study visit. We will use the routine visit (at 10-
12 weeks) to record data for the study. The routine clinical follow up will be up to 5 years. 
11.7
 Schedule of Procedures and Observations
The schedule of procedures and observations for this study is summarized in Appendix D.
11.8
Blood Draws for Immune Marker Analysis
Research blood draws for immune marker analysis is optional for study participants.
Recent work from the Gollnick lab has demonstrated the critical role of the immune system in PDT 
efficacy. Because of the importance of the immune system for PDT efficacy, along with the 
potential for the immune system to mount an effective anti-tumor response, it would be beneficial 
to monitor immune markers (detailed in Section 2.6) for correlation between the I-PDT treatment 
and local or distant disease recurrence.
Blood samples will be collected via venipuncture for immune marker analysis. Samples will be 
collected using one 10 mL heparinized green-top collection tube. Tubes will be labeled with the 
participant’s initials, participant’s study number, clinical study number, protocol time point (i.e. 
prior to infusion of porfimer sodium, Day 0), dose, and protocol day.
Samples for immune marker analysis will be obtained on:

Day of 1st I-PDT prior to laser light illumination

7-10 days following 1st I-PDT.
All subsequent follow-up evaluations (if feasible):

Initial follow-up (approximately 4 weeks ± 1 week following 1st I-PDT 
NOTE: For subjects that need later 2nd and 3rd I-PDT sessions (as per Section 10.4), the research 
blood draws are taken per the physician’s discretion.
Whole blood samples collected at RP will be sent at room temperature for processing the same day 
of collection.
The samples should be sent to:
Roswell Park Comprehensive Cancer Center
Attn: Flow Cytometry – I 67918
Elm & Carlton Streets
Buffalo, New York 14263
716-845 3528 (8:30 am -5 pm)
flowlab@RoswellPark.org
Note: All investigator or analyzing research laboratories housing research samples need to 
maintain current Temperature Logs and study-specific Sample Tracking and Shipping Logs. 
The Principal Investigator/Laboratory Manager must ensure that the stated lab(s) have a process 
in place to document the receipt/processing/storage/shipping of study-related samples/specimens. 
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11.9
Pathology
Standard pathologic analysis of resected head and neck tissue and tumor will be performed.
12.0
Withdrawal of Subjects
Subject Withdrawal
The subject will be withdrawn from the study as described in Section 10.5 and if:

The I-PDT can't be administered. 

The patient would become hemodynamically unstable during I-PDT.
13.0
Risks to Subjects
This is a Greater Than Minimal Risk study according to IRB criteria. Phototoxicity is the most 
likely potential risk associated with the systemic administration of the porfimer sodium. Proper 
shielding from the procedure room lights will be maintained and the pulse oximetry sensor will be 
rotated every 15 minutes, to minimize this risk. The subjects will be provided with written 
instructions on how to protect themselves from excessive light exposure.
The site-specific toxicity associated with this therapy includes:
a.
Injection site reaction: Very common effects include pain at the injection site (12%) which 
is transient and can be minimized by slowing the injection rate. Common effects include 
injection site reaction (3%) and burning sensation (3%).
b. Tumor/local tissue reaction: Very common effects include pain (15%), hemorrhage (15%) 
and scaring (12%). Common effects include edema (8%), localized infection (8%), fever 
(8%), and skin necrosis (2%).
c.
Phototoxicity: Common effects include sunburn (3%), blisters (5%), erythema (5%), 
hyper-pigmentation (3%), and cutaneous photosensitivity (3%).
d. Other systemic events: Constipation (11%), vomiting (9%), anemia (8%), nausea (6%) and 
giddiness (2%).
e.
Collection of blood: Potential rare risks include local bleeding, inflammation and infection 
at the collection site (<1% of patients). 
14.0
Potential Benefits to Subjects
For subjects that will have partial or complete response to I-PDT, the potential benefits include 
reduction in tumor related side effects (such as bleeding, pain, and dysphagia). Subjects that do not 
respond to I-PDT may not benefit from this treatment. In addition it has been shown, in other 
diseases sites, that PDT can improve OS and PFS when added to SoC therapy. Thus, it is possible 
that subjects that will respond to the experimental arm (I-PDT + SoC) will have increased OS and 
PFS. There is no guarantee of the outcome nor is it possible to predict whether or not the subject 
will respond to porfimer sodium-mediated I-PDT.
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15.0
Data and Specimen Banking
Any clinical data that is associated with the samples will be stored on a secured server, will be 
accessible only by the PI, co-investigators and PI-designated data manager and, will be password 
protected. All computer entry and networking programs will be done using PIDs only.
Upon completion of sample assays the analyzing laboratories will provide results to Biostatistics 
and to CRS Data Management in a SAS compatible Excel file.
Note: All investigator or analyzing research laboratories housing research samples need to maintain 
current Temperature Logs and study-specific Sample Tracking and Shipping Logs. The Principal 
Investigator/Laboratory Manager must ensure that the stated lab(s) have a process in place to 
document the receipt/processing/storage/shipping of study-related samples/specimens. This is 
required for both observational and interventional clinical studies collecting clinical samples.
16.0
Measurement of Effect
16.1
Objective Disease Assessment
History, physical examination and standard CT will be used to monitor disease recurrence every 
1-3 months in the first year, and every 2-6 in year 2, following the 2018 NCCN follow-up 
guidelines for patients with advanced HNC 
(https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf) (63; Appendix H). 
Subsequently, the treating physician will continue the usual clinical disease monitoring. Ancillary 
imaging studies such as PET-CT or MRI will be performed as indicated in the judgment of the 
treating physician based on findings from the history, physical examination or CT. Biopsy of 
suspected recurrent disease will be performed when feasible with minimal risk to the patient.
16.2
Target Lesions 
The target lesions will be the locally advanced HNC that were treated with I-PDT or the ones that 
were identified by the principal investigator (or treating physician) as locally advanced and were 
treated with SoC therapy. Tumors measurements will take place 10-12 weeks after I-PDT or the 
first SoC in the control ram. Change in the target tumor size will be determine using the methods 
described in RECIST v1.1 (62). CT with contrast or MRI (when CT is not possible) will be used to 
determine change in tumor size. The objective response of the target tumor will be determined 
following these criteria: 

Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have 
a reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the baseline sum diameters. A biopsy will be taken from the suspected 
lesions for histological confirmation.

Progressive Disease (PD): At least a 20% increase in the diameters of target lesions, taking 
as references the smallest sum on study (this includes the baseline sum if that is the smallest 
on study). In addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of at least 5 mm. 
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
Stable Disease (SD): Neither, sufficient shrinkage to qualify for PR nor, sufficient increase 
to qualify for PD, taking as reference the smallest sum diameters while on study, the 
response will be listed with stable disease. In this case, a biopsy will be taken from the 
suspected lesion for histological confirmation.
16.3
Evaluation of Response
Time point response assessments will be performed according to the 2018-NCCN follow-up 
guidelines for patients with advanced HNC (63), up to 24 months after I-PDT. To determine time 
point response criteria, refer to Table 1 below.
Table 1 Time Point Response Criteria (+/- non-target disease)
Target Lesions
Non-Target Lesions
New Lesions
Overall Response
CR
CR
No
CR
CR
Non-CR/Non-PD
No
PR
CR
Not evaluated
No
PR
PR
Non-PD or not all evaluated
No
PR
SD
Non-PD or not all evaluated
No
SD
Not all evaluated
Non-PD
No
NE
PD
Any
Yes or No
PD
Any
PD
Yes or No
PD
Any
Any
Yes
PD
Table 2. Time Point Response Criteria (non-target disease only)
Non-Target Lesions
New Lesions
Overall Response
CR
No
CR
Non-CR/non-PD
No
Non-CR/non-PD1
Not all evaluated
No
NE
Unequivocal PD
Yes or No
PD
Any
Yes
PD
1   Non-CR/non-PD is preferred over SD for non-target disease since SD is used as endpoint for assessment of 
efficacy in trials so to assign this category when no lesions can be measured is not advised.
The best overall response is the best response recorded from the start of study treatment until 
follow-up is completed or the participant goes off study (the end of treatment taking into account 
any requirement for confirmation).

Symptomatic Deterioration: Participants with global deterioration of health status requiring 
study withdrawal without objective evidence of disease progression at that time, and not related 
to study treatment or other medical conditions should be reported as progressive disease due to 
“symptomatic deterioration.” Every effort should be made to document objective progression 
even after discontinuation of treatment due to symptomatic deterioration. Symptomatic 
deterioration that may lead to study withdrawal includes, but is not limited to, symptoms such 
as:
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o
Weight loss > 10% of body weight.
o
Worsening of disease-related symptoms (e.g., worsening dyspnea, increasing 
pain/increasing requirement for narcotic analgesics).
o
Decline in performance status of > 1 level on ECOG scale.
16.4
Guidelines for Evaluation of Measurable Disease
All baseline evaluations should be performed as closely as possible to the beginning of treatment 
and never more than 4 weeks before the beginning of the treatment.
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at baseline and during follow-up. Imaging-based evaluation is 
preferred to evaluation by clinical examination unless the lesion(s) being followed cannot be 
imaged but are assessable by clinical exam.

Conventional CT and MRI: This guideline has defined measurability of lesions on CT scan 
based on the assumption that CT slice thickness is 5 mm or less. If CT scans have slice 
thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the 
slice thickness. MRI is also acceptable in certain situations.
17.0
Safety Evaluation
17.1
Adverse Events
An adverse event or adverse experience (AE) is any untoward medical occurrence associated with 
the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY 
unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a medicinal (investigational) product, whether or not 
considered related to the medicinal (investigational) product (attribution of ‘unrelated’, ‘unlikely’, 
‘possible’, ‘probable’, or ‘definite’).
An AE is considered “unexpected” if it is not listed in the investigator brochure or is not listed at 
the specificity or severity that has been observed; or if an investigator brochure is not required or 
available, is not consistent with the risk information described in the general investigational plan in 
other study-related documents.
17.1.1  DIAGNOSIS VERSUS SIGNS AND SYMPTOMS
If known, a diagnosis should be recorded on the CRF rather than individual signs and symptoms 
(e.g., record only liver failure or hepatitis rather than jaundice, asterixis, and elevated 
transaminases). However, if a constellation of signs and/or symptoms cannot be clinically 
characterized as a single diagnosis or syndrome at the time of reporting, each individual event 
should be recorded as an AE or SAE on the CRF. If a diagnosis is subsequently established, it 
should be reported as follow-up information.
17.1.2  ADVERSE EVENTS OCCURRING SECONDARY TO OTHER EVENTS
In general, AEs occurring secondary to other events (e.g., cascade events or clinical sequelae) 
should be identified by their primary cause. For example, if severe diarrhea is known to have 
resulted in dehydration, it is sufficient to record only diarrhea as an AE or SAE on the CRF. 
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However, clinically significant AEs occurring secondary to an initiating event that are separated in 
time should be recorded as independent events on the CRF. For example, if a severe gastrointestinal 
hemorrhage leads to renal failure, both events should be recorded separately on the CRF.
17.1.3  ABNORMAL LABORATORY VALUES
Only clinically significant laboratory abnormalities that require active management will be 
recorded as AEs or SAEs on the CRF (e.g., abnormalities that require study drug dose modification, 
discontinuation of study treatment, more frequent follow-up assessments, further diagnostic 
investigation, etc.).
If the clinically significant laboratory abnormality is a sign of a disease or syndrome (e.g., alkaline 
phosphatase and bilirubin 5 x the upper limit of normal associated with cholecystitis), only the 
diagnosis (e.g., cholecystitis) needs to be recorded on the Adverse Event CRF.
If the clinically significant laboratory abnormality is not a sign of a disease or syndrome, the 
abnormality itself should be recorded as an AE or SAE on the CRF. If the laboratory abnormality 
can be characterized by a precise clinical term, the clinical term should be recorded as the AE or 
SAE. For example, an elevated blood potassium level of 7 mEq/L should be recorded as 
“hyperkalemia.”
Observations of the same clinically significant laboratory abnormality from visit to visit should not 
be repeatedly recorded as AEs or SAEs on the CRF, unless their severity, seriousness, or etiology 
changes.
17.1.4  PREEXISTING MEDICAL CONDITIONS (BASELINE CONDITIONS)
A preexisting medical condition should be recorded as an AE or SAE only if the frequency, severity, 
or character of the condition worsens during the study. When recording such events on an Adverse 
Event CRF, it is important to convey the concept that the preexisting condition has changed by 
including applicable descriptors (e.g., “more frequent headaches”).
17.2
Grading and Reporting Adverse Events
17.2.1  GRADING AND RELATIONSHIP TO DRUG
The descriptions and grading scales found in the CTEP Version 5.0 of the NCI Common CTCAE 
will be utilized for AE reporting. CTEP Version 5.0 of the CTCAE is identified and located at:
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
AEs not covered by specific terminology listed should be reported with common medical 
terminology, and documented according to the grading scales provided in the CTCAE Version 5.
The relationship of event to study drug will be documented by the Investigator as follows:

Unrelated: The event is clearly related to other factors such as the participant’s clinical 
state, other therapeutic interventions or concomitant drugs administered to the participant.

Unlikely: The event is doubtfully related to investigational agent(s). The event was most 
likely related to other factors such as the participant’s clinical state, other therapeutic 
interventions, or concomitant drugs.
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
Possible: The event follows a reasonable temporal sequence from the time of drug 
administration, but could have been produced by other factors such as the participant’s 
clinical state, other therapeutic interventions or concomitant drugs.

Probable: The event follows a reasonable temporal sequence from the time of drug 
administration, and follows a known response pattern to the study drug. The event cannot 
be reasonably explained by other factors such as the participant’s clinical state, therapeutic 
interventions or concomitant drugs.

Definite: The event follows a reasonable temporal sequence from the time of drug 
administration, follows a known response pattern to the study drug, cannot be reasonably 
explained by other factors such as the participant’s condition, therapeutic interventions or 
concomitant drugs; AND occurs immediately following study drug administration, 
improves upon stopping the drug, or reappears on re-exposure.
17.3
Reporting Adverse Events
Routine AEs occurring between the start date of intervention until 30 days after the last 
intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a 
new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be 
reported. New information will be reported after it is received.
Table 1 Guidelines for Routine Adverse Event Reporting for Phase 1 Studies (Regardless of 
Expectedness)
Attribution
Grade 1
Grade 2
Grade 3
Grade 4
Unrelated
X
X
X
X
Unlikely
X
X
X
X
Possible
X
X
X
X
Probable
X
X
X
X
Definite
X
X
X
X
Routine AEs occurring between the start of intervention until 30 days after the last intervention or 
until the event has resolved, stabilized, death, or a new treatment is started, whichever comes first, 
will be reported. New information will be reported after it is received.
Pinnacle Biologics, Inc. Bannockburn IL, will be receiving copies of all the reports (de-identified).
17.4
Serious Adverse Events
A serious adverse event (SAE) is any adverse event (experience) that in the opinion of either the 
investigator or sponsor results in ANY of the following:

Death.

A life-threatening adverse event (experience). Any AE that places a participant or 
participants, in the view of the Investigator or sponsor, at immediate risk of death from the 
reaction as it occurred. It does NOT include an AE that, had it occurred in a more severe 
form, might have caused death.

Inpatient hospitalization or prolongation of existing hospitalization (for > 24 hours).
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
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions.

A congenital anomaly or birth defect.

Important Medical Event (IME) that, based upon medical judgment, may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes 
listed above.
17.4.1 REPORTING SERIOUS ADVERSE EVENTS
All new SAEs occurring from the date the participant signs the study consent until 30 days after the 
last intervention or a new treatment is started, whichever comes first, will be reported. The RPCI 
SAE Source Form is to be completed with all available information, including a brief narrative 
describing the SAE and any other relevant information. 
SAEs occurring after the 30 day follow-up period that the investigator determines to be possibly, 
probably or definitely related to the study intervention should be reported.
SAEs that are unexpected and possibly, probably or definitely related must be reported as an 
Unanticipated Problem. Please refer to Section 17.6 for details on reporting Unanticipated 
Problems.
17.5
Follow-Up for Serious Adverse Events
All related SAEs should be followed to their resolution, until the study participant is lost to 
follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable 
or irreversible. New information will be reported when it is received.
17.6
Unanticipated Problems
An Unanticipated Problem (UP) is any incident, experience, or outcome that meets all of the 
following criteria:

Unexpected (in terms of nature, severity, or frequency) given:
o
The research procedures that are described in the study-related documents, including 
study deviations, as well as issues related to compromise of participant privacy or 
confidentiality of data.
o
The characteristics of the participant population being studied.

Related or possibly related to participation in the research (possibly related means there is 
a reasonable possibility that the incident, experience, or outcome may have been caused by 
the procedures involved in the research).

Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized or if in relation to an AE is deemed Serious per Section 17.4.
17.6.1 REPORTING UNANTICIPATED PROBLEMS
Unanticipated problem reporting will begin at the time of participant consent. The Reportable New 
Information (RNI) Form will be submitted to the CRS Quality Assurance (QA) Office within 1 
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business day of becoming aware of the Unanticipated Problem. After review, CRS QA Office will 
submit the RNI to the IRB.
When becoming aware of new information about an Unanticipated Problem, submit the updated 
information to CRS QA Office with an updated Reportable New Information Form. The site 
Investigator or designated research personnel will report all unanticipated problems, whether 
related or unrelated to the investigational agent(s) to the IRB in accordance with their local 
institutional guidelines.
17.7
FDA Reporting
When Roswell Park is the IND holder the following describes the FDA reporting requirements by 
timeline for AEs and new safety findings that meet the criteria outlined below:
Within 7 Calendar Days
Any adverse event that meets ALL the following criteria:

Related or possibly related to the use of the study drug;

Unexpected; and

Fatal or life-threatening.
Within 15 Calendar Days
Any adverse event that meets ALL the following criteria:

Related or possibly related to the use of the study drug;

Unexpected; and

Serious but not fatal or life-threatening;
Or, meets ANY of the following criteria:

A previous adverse event that is not initially deemed reportable but is later found to fit the 
criteria for reporting (report within 15 days from when event was deemed reportable).

Any findings from other studies, including epidemiological studies, pooled analysis of 
multiple studies, or other clinical studies conducted with the study drug that suggest a 
significant risk in humans exposed to the drug.

Any findings from animal or in vitro testing that suggest a significant risk for human 
participants including reports of mutagenicity, teratogenicity, or carcinogenicity or reports 
of significant organ toxicity at or near the expected human exposure.

Any clinically important increase in the rate of occurrence of a serious, related or possibly 
related adverse event over that listed in the protocol or investigator brochure.
Sponsors are also required to identify in IND safety reports, all previous reports concerning similar 
adverse events and to analyze the significance of the current event in the light of the previous 
reports.
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17.8
Investigator Reporting: Notifying the Manufacturer of Porfimer Sodium
Investigators MUST report (within 1 business day), upon becoming aware, to Pinnacle Biologics, 
Inc. ANY Serious Adverse Events, whether or not they are considered related to the investigational 
agents using the forms supplied by Pinnacle.
Pinnacle reporting contact: fax (+1(905) 689-1465) or email (pinnaclesafety@optum.com).
17.9
Reporting Process
The principal investigator or designee will complete and submit a FDA Form 3500A MedWatch 
for any event that meets the above criteria. Forms will be submitted to the CRS QA Office via email 
to CRS-QA@RoswellPark.org.
18.0
Data Management and Confidentiality
18.1
Data Collection
Full build studies are managed by Roswell Park CRS Data Management for analysis by Roswell 
Park Biostatisticians. All electronic case report form (eCRF) data are captured for these studies.
Clinical data management activities are performed using CTMS and EDC systems that enable the 
collection, cleaning and viewing of clinical trial data. CRS Clinical Data manages, designs and 
develops the study-specific database Once the database design is approved by the Investigator, 
Statistician, and Clinical Research Coordinator, the database is put into Production and data entry 
can begin. Data can be entered and changed only by those with the rights to do so into the eCRFs. 
18.2
Maintenance of Study Documents
Essential documents will be retained per Roswell Park policy for 6 years from the study termination 
date. These documents could be retained for a longer period, however, if required by the applicable 
local regulatory requirements or by an agreement with Roswell Park.
18.3
Revisions to the Protocol
Roswell Park may make such changes to the protocol as it deems necessary for safety reasons or as 
may be required by the U.S. FDA or other regulatory agencies. Revisions will be submitted to the 
IRB/ERC for written approval before implementation.
18.4
Termination of the Study
It is agreed that, for reasonable cause, either the Roswell Park Investigators or the Sponsor, may 
terminate this study, provided a written notice is submitted within the time period provided for in 
the Clinical Trial Agreement. In addition, Roswell Park may terminate the study at any time upon 
immediate notice if it believes termination is necessary for the safety of participants enrolled in the 
study.
18.5
Confidentiality
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain 
confidentiality. All records will be kept in a limited access environment. All computer entry and 
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networking programs will be done using PIDs only. Information will not be released without written 
authorization of the participant.
19.0
Statistical Plan
This is a Phase 1 trial. The primary objective of the Phase 1 component is to test the safety of 
porfimer sodium mediated I-PDT in patients with locally advanced or recurrent HNC who are not 
candidates for standard or salvage surgery or radiotherapy. 
19.1
Sample Size Determination
The maximum sample size is 12 patients. The actual sample size depends on the unknown dose-
toxicity profile of the treatment, see section 10.14 for the dose escalation scheme. 
19.2
 Demographics and Baseline Characteristics
Descriptive statistics such as frequencies and relative frequencies will be computed for all 
categorical variables. Numeric variables will be summarized using simple descriptive statistics such 
as the mean, standard deviation and range. A variety of graphical techniques will also be used to 
display data such as histograms, boxplots, scatterplots, etc.
19.3
 Safety Analysis
The safety will be determined by recording the occurrence of SAE during the first 30 days post first 
SOC treatment day (or last I-PDT day if no therapeutic SOC is given) using the revised NCI 
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Sequential boundaries 
will be used to monitor the SAE rate (64). The accrual will be halted if excessive numbers of SAEs 
are seen.
19.4
Exploratory
Objective tumor response rates at 10-12 weeks will be summarized with a sample proportion and 
corresponding 95% confidence interval. Time-to-event endpoints will be examined using a Cox 
regression model with a factors for I-PDT (yes/no), standard-of-care type (chemotherapy, targeted 
therapy, immunotherapy) and an interaction term. Survival curves will be estimated per group using 
Kaplan-Meier estimates. It is assumed a priori that any drop out times will be non-informative in 
terms of the censoring mechanism.
19.5
 Quality-of-Life Analysis
UW-QoLQ v4 will be calculated at baseline and at 30 days post final treatment. The primary 
analysis will consist of examining the change from baseline to Day 30 using a Wilcoxon sign-rank 
test.
19.6
 Adverse Events
The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects 
who receive any study treatment will be considered evaluable for toxicity.
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19.7
 Interim Analysis and Criteria for Early Termination of the Study
A formal stopping rule for safety is given in Section 19.1. In addition, the Phase 1 study will be 
monitored and discussed by Roswell Park’s Early Phase Clinical Trials Committee, which meets 
on a regular basis per the Roswell Park Data Safety Monitoring Plan. Drug safety will be monitored 
and evaluated continuously throughout the study including 30-day safety follow-up period by 
obtaining, reviewing and analyzing data on AEs, changes in laboratory values, vital signs, 
electrocardiograms (ECGs), and physical examination findings. Potential early termination 
decisions are an inherent part of the Phase 1 study monitoring.
Specific attention will be paid to incidents of:
1.  Life threatening hemorrhaging
2.  Airway compromise leading to emergency intubation or tracheostomy
19.8
Correlative Data Analysis
Study metrics will be summarized using simple descriptive statistics such as the mean, standard 
deviation, range, etc. Ninety-five percent confidence intervals will be computed when appropriate. 
A variety of graphical techniques will also be used to display data.
Light Dosimetry
In all participating sites, the light dosimetry system, described in Section 32.2, will be used to 
measure light dose during the entire treatment at several key locations within the treated area. The 
light dosimetry system will be stored and maintained in Dr. Shafirstein laboratory at Roswell 
Park. The system will be provided to the site before the procedure and returned to Roswell Park, 
after the procedure. Dr. Shafirstein or one of his research team members will operate the system 
during the I-PDT procedure. 
During I-PDT, each detector will be marked (with a number) and the data from each location will 
be saved with information on the location and time of measurement. The primary measurable 
outputs will be the light fluence (J/cm2) and fluence rate (mW/cm2) at each location.
20.0
Provisions to Monitor the Data to Ensure the Safety of Subjects
All Roswell Park studies will be reviewed at the scheduled Early Phase Clinical Trial Committee 
meetings. 
The Roswell Park Data and Safety Monitoring Committee (DSMC) will assess the progress of the 
study, the safety data, and critical efficacy endpoints. The DSMC will review the study and will 
make recommendations that include but not limited to; (a) continuation of the study, (b) 
modifications to the design, (c) suspension of, or (d) or termination of the study.
21.0
Vulnerable Populations
Not applicable.
22.0
Community-Based Participatory Research
Not applicable.
23.0
Sharing of Results with Subjects
Individual response data is shared with the participant as a part of their clinical care.
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24.0
Setting
Participants will receive porfimer sodium as an outpatient in the Head and Neck Clinic and PDT 
will occur at inpatient surgery at Roswell Park and participating sites.
25.0
Provisions to Protect the Privacy Interests of Subjects
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain 
confidentiality. All records will be kept in a limited access environment. All computer entry and 
networking programs will be done using PIDs only. Information will not be released without written 
authorization of the participant.
26.0
Resources Available
Not Applicable.
27.0
Prior Approvals
Not Applicable.
28.0
Compensation for Research-Related Injury
For Roswell Patients only, if the subject believes they have been injured as a direct result of their 
participation in this research study, they will be advised to notify the Roswell Park Patient Advocate 
at (716) 845-1365 or the Study Doctor at (716) 845-4094.
Medical diagnosis and treatment for the injury will be offered, and a determination will be made 
regarding appropriate billing for the diagnosis and treatment of the injury. A financial counselor 
(716-845-3161) will be able to provide an explanation of coverage and to answer questions the 
subject may have regarding study related billing.
The subject is not prevented from seeking to collect compensation for injury related to malpractice, 
fault, or blame on the part of those involved in the research.
29.0
Economic Burden to Subjects
The participants will not be subject to any economic burden.
30.0
Consent Process
This study will not be initiated until the protocol and informed consent document(s) have been 
reviewed and approved by a properly constituted Institutional Review Board (IRB) or Independent 
Ethics Committee (IEC). Each participant (or legal guardian) shall read, understand, and sign an 
instrument of informed consent prior to performance of any study-specific procedure. It is the 
responsibility of the investigator to ensure that the participant is made aware of the investigational 
nature of the treatment and that informed consent is given.
The Investigator is responsible for the retention of the participant log and participant records; 
although personal information may be reviewed by authorized persons, that information will be 
treated as strictly confidential and will not be made publicly available. The investigator is also 
responsible for obtaining participant authorization to access medical records and other applicable 
study specific information according to Health Insurance Portability and Accountability Act 
regulations (where applicable).
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This study will be conducted in compliance with all applicable laws and regulations of the state 
and/or country and institution where the participant is treated. The clinical trial should be conducted 
in accordance with the ethical principles embodied in the Belmont Report: Ethical Principles and 
Guidelines for the Protection of Human Subjects of Research, consistent with good clinical practice 
and the applicable regulatory requirements and according to the guidelines in this protocol, 
including attached appendices.
31.0
Process to Document Consent in Writing
The Investigator (or IRB specified designee) is responsible for obtaining written consent from each 
participant in accordance with GCP guidelines using the approved informed consent form, before 
any study specific procedures (including screening procedures) are performed. The informed 
consent form acknowledges all information that must be given to the participant according to 
applicable GCP guidelines, including the purpose and nature of the study, the expected efficacy and 
possible side effects of the treatment(s), and specifying that refusal to participate will not influence 
further options for therapy. Any additional information that is applicable to the study must also be 
included. Additional national or institutionally mandated requirements for informed consent must 
also be adhered to. The participant should also be made aware that by signing the consent form, 
processing of sensitive clinical trial data and transfer to other countries for further processing is 
allowed.
The Investigator shall provide a copy of the signed consent form to the participant and the signed 
original shall be maintained in the Investigator File. A copy of the signed consent form must be 
filed in the participant file. At any stage, the participant may withdraw from the study and such a 
decision will not affect any further treatment options.
32.0
Drugs or Devices
32.1
Porfimer Sodium
The porfimer sodium will be provided, at no cost, to the patients or their insurance.
32.1.1 ACTIVE SUBSTANCE AND SOURCE
Porfimer sodium for injection is supplied as a freeze-dried cake or powder as follows: NDC 76128-
155-75, 75 mg vial.
32.1.2 DRUG SHIPMENT
Porfimer sodium (Photofrin®) will be provided and shipped by Pinnacle Biologics Inc. to all 
participating sites. The receiving site will document the date of receipt and condition of the 
shipment. Drug shipment records will be retained by the investigational pharmacist or designee.
Roswell Park will provide the participating sites with instructions whom to contact and how to order 
the Photofrin® vials from Pinnacle Biologics Inc. The company will provide few vials when the 
study is approved and prior to open for enrollment at each site. More vials will be provided few 
days before each participant will be scheduled for treatment. The vials will be labeled and can be 
used for this study, only. 
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32.1.3 PREPARATION
Porfimer Sodium will be prepared for injection following the manufacturer instructions: 
"Reconstitute each vial of porfimer sodium with 31.8 mL of either 5% Dextrose Injection (USP) or 
0.9% Sodium Chloride Injection (USP), resulting in a final concentration of 2.5 mg/mL: Shake well 
until dissolved. Do not mix porfimer sodium with other drugs in the same solution.
Porfimer sodium reconstituted with 5% Dextrose Injection (USP) or with 0.9% Sodium Chloride 
Injection (USP), has a pH in the range of 7 to 8. Porfimer sodium has been formulated with an 
overage to deliver the 75 mg labeled quantity. The reconstituted product should be protected from 
bright light and used immediately. Reconstituted porfimer sodium is an opaque solution, in which 
detection of particulate matter by visual inspection is extremely difficult. Reconstituted porfimer 
sodium, however, like all parenteral drug products, should be inspected visually for particulate 
matter and discoloration prior to administration whenever solution and container permit area from 
light. 
32.1.4 STORAGE AND STABILITY
Porfimer sodium freeze-dried cake or powder will be stored at Controlled Room Temperature 20–
25°C (68–77°F). 
The Investigator or designate will be responsible for ensuring that the investigational product is 
securely maintained in a locked, limited-access facility, as specified by the Sponsor and in 
accordance with the applicable regulatory requirements.
Drug storage temperature will be maintained and recorded, as applicable.
32.1.5 HANDLING AND DISPOSAL
Under no circumstances will the Investigator supply porfimer sodium to a third party or allow it to 
be used in a manner other than as directed by this protocol.
32.2
Light Dosimetry System
All participating sites will have a light dosimetry system that will be used to measure the light dose 
[fluence rate (mW/cm2) and fluence (J/cm2)]. The dosimetry system (shown in Figure 4) has been 
developed at Dr. Shafirstein laboratory at Roswell Park. This system has been used to treat patients 
with head a neck cancer in a compassionate care settings (36), and in ongoing studies to guide 
intraoperative PDT in the treatment of treat patient with lung cancer. (48) The console of this light 
dosimetry system is shown in Figure 4 below. The data is recorded and stored on a password 
secured personal computer. 
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Figure 4Dosimetry System screen layout 
32.3
Laser Systems
These laser systems will be shipped before the procedure and send back after each procedure. The 
laser will be shipped at least one day prior to I-PDT, to allow the laser safety officer to examine the 
laser/s (at each participating site). The laser systems will not stay in any site, they will be shipped 
back and forth as described above. All participating sites will use the following or comparable laser 
systems:
1. An experimental medical PDT diode laser (ML7710-630-6W, Modulight Inc. Tampere, 
Finland). This system emits light with a wavelength of 630 ± 3 nm up to 6 W. It includes SMA-
905 connector, fiber sensor, integrated dose calibration unit (for 10-70 mm diffuser fibers), 
power control, dose calibration, and a foot pedal switch. It is used under IND in another study 
(I 256814).
2. The Modulight laser (ML7710-630, medical laser system, 630 ± 3 nm, 2 x 2.5 W (400 μm 
NA=0.22) individually controls laser fiber outputs with a SMA-905 connector and fiber sensors. 
It includes SMA-905 connector, fiber sensor, integrated dose calibration unit (for 10-70 mm 
diffuser fibers), power control, dose calibration, and a foot pedal switch. 
The Modulight lasers have CE 0537, 93/42 EEC and ISO 13485 certifications to design and 
manufacture medical laser systems for PDT. The Modulight’s ML7710-PDT platform has been 
specifically designed for illumination in PDT treatment processes, to meet the requirements in dose 
calibration, power stability and wavelength tolerance. The ML7710-630 version designed 
specifically for porfimer sodium. It has CB certification and design documentation for CE/FDA. 
These lasers, owned by Roswell Park, can reduce the treatment time significantly.
3. One or more DIOMED 630 PDT Laser. This laser system emits 630 ± 3 nm up to 2 Watts. The 
FDA approved the use of this laser for PDT with porfimer sodium. Pinnacle Biologics Inc. 
The light dosimetry system that will be used in this study: The screen layout of the dosimetry system. The light 
fluence rate (mW/cm2) and fluence (J/cm2) are continuously updated during therapy and presented on a LCD screen, so 
the treating physician can monitor the light delivery in real-time. In this example the integration period (pointed with a 
red arrow) or acquisition time is 20 milliseconds (ms) to obtain high signal to noise ratio reading as shown on the right, 
for 630±3 nm laser light.
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provides this laser system at no cost to physicians that administer PDT with Photofrin®. This 
service is offered for all customers including Roswell Park. The laser is shipped 1-2 days prior 
to the procedure. The laser safety officer inspects it prior to treatment. The laser is sent back (to 
Pinnacle Biologics, Inc.) after treatment. This arrangement has been worked well for the past 
few years.
32.4
Cylindrical Light Diffuser and Dosimetry fibers
The I-PDT will be accomplished by delivering diffuse red light with fiber with cylindrical light 
diffuser end that will be connected to one of the lasers systems described above (section 32.3). A 
general description of these fibers can be found in Shafirstein et al. 2017.(47) In the study described 
herein, we will use fiber with cylindrical light diffuser end that can have 10, 20, 30, 40 or 50 mm 
length diffuser end (RD10-RD50, Medlight SA, Ecublens, Switzerland) and/or clinically approved 
cylindrical diffuser fibers (OPTIGUIDE® DCYL700 series 1, 1.5, 2.0, 2.5 and 5.0 cm, Pinnacle 
Biologics Inc. Bannockburn, IL). 
For light dosimetry, we will use detection fibers with an isotropic probe end (IP, Medlight SA, 
Ecublens, Switzerland). We use these fibers in another clinical study that utilize PDT for the 
treatment of lung cancer.(48) 
Medlight is ISO 13485 and ISO 9001 certified manufacturer. All their devices are CE marked, and 
are designed, marketed and used for PDT in the EU, and in many clinical studies. The USA FDA 
has successfully inspected Medlight on April 10-11, 2000.
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33.0
References
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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018;68(1):7-30. 
doi: 10.3322/caac.21442. PubMed PMID: 29313949.
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Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014;64(1):9-29. 
doi: 10.3322/caac.21208. PubMed PMID: 24399786.
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Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017;67(1):7-30. 
doi: 10.3322/caac.21387. PubMed PMID: 28055103.
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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30. 
doi: 10.3322/caac.21332. PubMed PMID: 26742998.
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Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015;65(1):5-29. 
doi: 10.3322/caac.21254. PubMed PMID: 25559415.
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34.0
Appendices/ Supplements
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Appendix A ECOG Performance Status Scores
Description
Status
Fully active, able to carry on all pre-disease performance without restriction.
0
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light 
or sedentary nature, e.g., light housework, office work.
1
Ambulatory and capable of all self-care but unable to carry out any work activities.
2
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
3
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
4
Dead
5
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Appendix B Inclusion Criteria Checklist
INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM:
INCLUSION CRITERIA
Participant Name:_____________________________
Medical Record No.:_______________________________
Title: A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment 
of Patients with Locally Advanced or Recurrent Head and Neck Cancer.
INCLUSION CRITERIA
Yes
No
N/A
All answers must be “Yes” or “N/A” for participant enrollment.
Date
1.
Male or female patients age ≥ 18 years of age.
2.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) 
performance status score of 0 – 2. Refer to Appendix A.
3.
Patients with locally advanced or recurrent head and neck cancer who 
failed to respond to standard therapy and are not amenable to standard 
curative treatment
4.
Tumor accessible for unrestricted illumination for interstitial 
photodynamic Therapy (I-PDT) (accessibility as determined by the 
physician).
5.
Life expectancy of at least 6 months, in the judgment of the physician.
6.
Subjects of child-bearing potential must agree to use adequate 
contraceptive methods (e.g., hormonal or barrier method of birth control; 
abstinence) prior to study entry and for the duration of study 
participation. Should a woman become pregnant or suspect she is 
pregnant while she or her partner is participating in this study, she should 
inform her treating physician immediately.
7.
Subject must understand the investigational nature of this study and sign 
an Institutional Review Board approved written informed consent form 
prior to receiving any study related procedure.
Investigator Signature: ___________________________________
Date: ___________
Printed Name of Investigator: __________________________________________________
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Appendix C Exclusion Criteria Checklist
INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM:
EXCLUSION CRITERIA
Participant Name:______________________
Medical Record No.:________________________
Title: A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the Treatment 
of Patients with Locally Advanced or Recurrent Head and Neck Cancer.
EXCLUSION CRITERIA
Yes
No
N/A
All answers must be “No” or “N/A” for participant enrollment.
Date
1.
High dose curative radiotherapy within 30 days in the area to be treated. 
2.
Tumor invading a major blood vessel.
3.
Tumor is not measurable on a CT or MRI scan according to RECIST 
v1.1. 
4.
Location and extension of the tumor precludes a potentially effective 
I-PDT.
5.
Patients with known brain metastases should be excluded from this 
clinical trial because of their poor prognosis and because they often 
develop progressive neurologic dysfunction that would confound the 
evaluation of neurologic and other adverse events.
6.
Patients with porphyria, or with known hypersensitivity to porphyrins or 
porphyrin-like compounds.
7.
Platelet count < 75,000.
8.
Patients with impaired renal and/or hepatic function (total serum 
bilirubin > 2 mg/dL, serum creatinine > 2 mg/dL, alkaline phosphatase 
(hepatic), SGOT or SGPT > 3 times the upper normal limit.
9.
Patients with moderately to severely impaired creatinine clearance (CrCl 
<44) will be excluded.
10. Uncontrolled intercurrent illness including, but not limited to, ongoing 
or active infection, symptomatic congestive heart failure, unstable 
angina pectoris, cardiac arrhythmia, or psychiatric illness/social 
situations that would limit compliance with study requirements.
11. Pregnant or nursing female subjects.
12. Unwilling or unable to follow protocol requirements.
13. Any condition which in the Investigator’s opinion deems the subject an 
unsuitable candidate to receive porfimer sodium.
Participant meets all entry criteria:
  Yes
  No
If “NO”, do not enroll participant in study.
Investigator Signature: ___________________________________
Date: ___________
Printed Name of Investigator: __________________________________________________
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Appendix D Schedule of Procedures and Observations if Only I-PDT Course is Necessary
Evaluation
Baseline1
Pre-
Operative
Day of 
Treatment
Day 1 Post 
Treatment
1-week 
Post-
treatment
Optional  
I-PDT  
Course 2 
Within 2-3 
Weeks of 
Day 017 
Clinic 
Visit2,2a
30-
Day 
Post I-
PDT 14
Optional I-
PDT 
Treatment 
additional 
2 or 3 At 
least 6 
Weeks 
after last I-
PDT 
Session18
Follow-
Up
Informed Consent
X
Medical History
X
X
Physical Exam/ Vital signs & pain 
assessment using a verbal score 0-
103
X
X
X
X
X
X
Hematology4 and Chemistry5
X
X
X
X
X
Research Blood Draws6
X
X
X
X
X
Pregnancy Test (Urine)
X
X
ECOG Performance Status
X
X
X
X
X
X
X
UW-QoLQ v. 415
X
X
X
X
X
X
Standard Imaging of the head and 
neck with CT or MRI, for RECIST 
v11.1
X7
X
X8
Treatment planning 
X
X
Porfimer Sodium administration 
and Vital Signs 
X9
X
Intraoperative Ultrasound 
X
X
If possible, intraoperative CT or 
other clinically approved 
radiological imaging 
X10
X10
X10
Interstitial PDT (I-PDT) 16
X11
X11
X11
Concomitant Medications
X12
X
Adverse Events13
X
X
X
X


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Notes:
* The I-PDT procedure is termed a “course”.
1. Performed within 8 weeks prior to porfimer sodium.
2. Performed at Day 1of SOC therapy. 
2a: If later 2nd and 3rd I-PDT courses are deemed necessary per the physician (see Section 10.4), please refer to Appendix D 1 
for treatment, procedure, and test scheduling.
3. Temperature, heart rate, respiratory rate, blood pressure, body weight and, height, Height collected at baseline only. Refer to 
Section 11.2.
4. Hematology (i.e., CBC (with auto differential), ANC, and platelets). Refer to Section 11.2.
5. Chemistry (i.e., AST, ALT, total bilirubin, alkaline phosphatase, creatinine, potassium, glucose, and calcium). Refer to Section 
11.2.
6. This is optional. Refer to immune markers Section 11.8 (1, 10 mL green-top tube).  
7. Standard tumor staging performed within 4 weeks, and at least 14 business days prior to I-PDT. If possible, the imaging will 
include temporary fiducial markers that will be affixed to skin. Refer to Section 11.2.
8. CT scans at 10 to 12 weeks post SOC therapy and as clinically indicated following the NCNN 2018 guidelines. 
9. Infusion will occur 48 hours ±8 h prior to illumination. Vitals are to be taken immediately after injection and after 15 minutes.
10. If possible, intraoperative CT (such as O arm) or another radiological imaging (e.g. C-arm) will be used to image the catheters 
in the tumor. 
11. Refer to Section 10.2.1.
12. Medications ongoing within 1 week prior to porfimer sodium injection.
13. AE reporting period will be for 30 days ± 2 days post first SOC treatment.
14. First SOC treatment day of I-PDT day if no therapeutic SOC treatment is administered.
15. Refer to Section 11.6f patient doesn’t come in or quality of life is missed, may be done via telephone.
16. In the event that the tumor size is such that treating the entire tumor could cause a health risk to the patient, the current I-PDT 
course will be broken up into session/ s. We will illuminate one part of the tumor on the day of I-PDT and another part/s of the 
tumor in additional I-PDT session/s within 14 days after the initial I-PDT session, at the discretion of the treating physician. If 


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an I-PDT course is broken up into I-PDT sessions, the I-PDT dosage for each session will remain the same as though sessions 
were not broken up as dosing is dependent on number of fibers received per session. The patient will not need to receive 
additional doses of porfimer sodium if having additional I-PDT sessions within 14 days after the previous I-PDT session as 
porfimer sodium is expected to be in the tumor for at least 30 days.
17. Another (one or two, total of three) laser light treatment(s) only (no additional drug) within 2-3 weeks of the initial administration 
of Photofrin.
18. Patient may receive a second complete I-PDT treatment that will include drug and light administration. It will be at the discretion 
of the treating physician to administer this additional treatment. Another CT (charged to the study if it is not SoC) will be done, 
and all tests will be conducted before and after additional treatment, according to the same schedule parameters as the initial 
treatment.


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Appendix D 1 Schedule of Procedures and Observations (Only for Dose Escalation later I-PDT Sessions if Deemed Necessary 
by Physician)**
Evaluation
Repeat of 
Initial Tests 
and 
Procedures A
Pre-
Operative
Day of 
Treatment
1-week Post-
treatment
Clinic 
Visit 
Post-
Treatment 
p
Follow-
Up 
Physical Exam/ Vital signs B& pain assessment 
using a verbal score 0-10
X
X
X
X
X
Hematology C and Chemistry D
X
X
X
X
Research Blood Draws E
X
X
X
X
X
Pregnancy Test (Urine)
X
ECOG Performance Status
X
X
X
X
X
X
UW-QoLQ v. 4p
X
X
X
X
X
Fresh Tissue Tumor BiopsyF
X
X
Standard Imaging of the head and neck with 
CT or MRIG
XH
XI
Treatment planning 
X
Porfimer Sodium administration and Vital 
Signs 
XJ
Intraoperative Ultrasound Q
X
If possible, intraoperative CT or other clinically 
approved radiological imaging 
XK
Interstitial PDT (I-PDT)
XL, Li
Concomitant Medications
XM
X
Standard of care (SoC) chemotherapy, targeted 
therapy or potentially immunotherapy as first 
line palliative care treatment options
XN
Adverse Events O
X Oi
X
X
X
X
Notes:
* The I-PDT procedure is termed a “course”. As per later Section 10.4, study participants may have up to 3 I-PDT courses per physician’s 
discretion, at least 30 days from the previous illumination procedure.


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** NOTE: 2nd and 3rd I-PDT courses are per the physician’s discretion as per Section 10.4, 2nd and 3rd I-PDT courses are not required 
for all study participants. If it is decided participants should receive all 3 I-PDT courses, items from “Repeat of Initial Tests and 
Procedures” until the completion of I-week Post treatment” are completed twice before the Clinic Visit and start of Standard of Care 
chemotherapy.
A. Performed within 4 weeks prior to 2nd and 3rd I-PDT courses. Since there may be up to three I-PDT courses, at least 30 days 
apart (see Section 10.4) per the physician’s discretion, the initial procedures, exams, or tests may be completed up to two more 
times based on the individual participant’s study treatment regimen. Research blood draws, standard imaging of head and neck 
with CT or MRI, and treatment planning for later I-PDT courses are per physician’s discretion.
B. Temperature, heart rate, respiratory rate, blood pressure, and body weight. Refer to Section 11.2.
C. Hematology (i.e., CBC (with auto differential), ANC, and platelets). Refer to Section 11.2.
D. Chemistry (i.e., AST, ALT, total bilirubin, alkaline phosphatase, creatinine, potassium, glucose, and calcium). Refer to Section 
11.2. 
E. This is optional. Research blood draws for any 2nd and 3rd I-PDT courses (all timepoints) are per the physician’s discretion. 
Refer to immune markers Section 11.8 (1 green top tube). 
F. If required per physician’s discretion, standard tumor staging performed within 4 weeks, and at least 14 business days prior to 
following I-PDT. If possible, the imaging will include temporary fiducial markers that will be affixed to skin. Refer to Section 
11.2.
G. CT scans at 10 to 12 weeks post I-PDT and as clinically indicated following the NCNN 2018 guidelines. 
H. If tumor results determine porfimer sodium infusion is needed for later 2nd and 3rd I-PDT sessions, infusion will occur 48 hours 
±8 h prior to illumination. Vitals are to be taken immediately after injection and after 15 minutes.
I.
If possible, intraoperative CT (such as O arm) or another radiological imaging (e.g. C-arm) will be used to image the catheters 
in the tumor. 
J.
Refer to Section 10.2.1.
K. Medications ongoing within 1 week prior to illumination.
L. Refer to Section 10.2.1.
Li. The later 2nd and 3rd I-PDT study treatments total as per the physician’s discretion are at least 30 days apart from each other 
(see Section 10.4). For additional I-PDT treatments that are 30 days from the previous that require an additional dosage of 
porfimer sodium the porfimer sodium (2mg/kg) is administered 48 hours prior to illumination.
M. AE reporting period will be for 30 days ± 2 days post first SOC treatment.
Oi. Since there may be up to three I-PDT courses, at least 30 days apart (see Section 10.4), per the physician’s discretion, 
adverse events review of previous study treatments are reviewed prior of the next additional I-PDT.
N. In Phase 1, patients are off treatment/on follow up as clinically indicated 30 days after the last I-PDT.
O. Refer to Section 11.6 if patient doesn’t come in or quality of life is missed, may be done via telephone. 


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P. In the event that the tumor size is such that treating the entire tumor could cause a health risk to the patient, the current I-PDT 
course will be broken up into session/s. We will illuminate one part of the tumor on the day of I-PDT and another part/s of the 
tumor in additional I-PDT session/s within 14 days after the initial I-PDT session, at the discretion of the treating physician. If 
an I-PDT course is broken up into I-PDT sessions, the I-PDT dosage for each session will remain the same as though sessions 
were not broken up as dosing is dependent on number of fibers received per session. The patient will not need to receive 
additional doses of porfimer sodium if having additional I-PDT sessions within 14 days after the previous I-PDT session as 
porfimer sodium is expected to be in the tumor for at least 30 days.
Q. The intraoperative ultrasound is done for 2nd and 3rd I-PDT courses, as per physician’s discretion.


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Appendix E University of Washington Quality of Life Questionnaire
Date: ___/___/____
Subject ID#______________
This questionnaire asks about your health and quality of life over the past seven days. Please 
answer all of the questions by checking one box for each question.
1.
Pain (Check one box: )

I have no pain.

There is mild pain not needing medication.

I have moderate pain - requires regular medication (codeine or nonnarcotic).

I have severe pain controlled only by narcotics.

I have severe pain, not controlled by medication.
2.
Appearance (Check one box: )

There is no change in my appearance.

The change in my appearance is minor.

My appearance bothers me but I remain active.

I feel significantly disfigured and limit my activities due to my appearance.

I cannot be with people due to my appearance.
3.
Activity (Check one box: )

I am as active as I have ever been.

There are times when I can't keep up my old pace, but not often.

I am often tired and have slowed down my activities although I still get out.

I don't go out because I don't have the strength.

I am usually in bed or chair and don't leave home.
4.
Recreation (Check one box: )

There are no limitations to recreation at home or away from home.

There are a few things I can't do but I still get out and enjoy life.

There are many times when I wish I could get out more, but I'm not up to it.

There are severe limitations to what I can do, mostly I stay at home & watch TV.
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I can't do anything enjoyable.5.Swallowing (Check one box: )

I can swallow as well as ever.

I cannot swallow certain solid foods.

I can only swallow liquid food.

I cannot swallow because it "goes down the wrong way" and chokes me.
6.
Chewing (Check one box: )

I can chew as well as ever.

I can eat soft solids but cannot chew some foods.

I cannot even chew soft solids.
7.
Speech (Check one box: )

My speech is the same as always.

I have difficulty saying some words but I can be understood over the phone.

Only my family and friends can understand me.

I cannot be understood.
8.
Shoulder (Check one box: )

I have no problem with my shoulder.

My shoulder is stiff but it has not affected my activity or strength.

Pain or weakness in my shoulder has caused me to change my work.

I cannot work due to problems with my shoulder.
9.
Taste (Check one box: )

I can taste food normally.

I can taste most foods normally.

I can taste some foods.

I cannot taste any foods.
10. Saliva (Check one box: )

My saliva is of normal consistency.

I have less saliva than normal, but it is enough. 

I have too little saliva. 

I have no saliva.
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11. Mood (Check one box:  )

My mood is excellent and unaffected by my cancer.

My mood is generally good and only occasionally affected by my cancer.

I am neither in a good mood nor depressed about my cancer.

I am somewhat depressed about my cancer.

I am extremely depressed about my cancer.
12. Anxiety (Check one box: )

I am not anxious about my cancer.

I am a little anxious about my cancer.

I am anxious about my cancer.

I am very anxious about my cancer.
Which issues have been the most important to you during the past 7 days?
Check  up to 3 boxes.

Pain
Swallowing 
Taste

Appearance 
Chewing

Saliva

Activity 
Speech 
Mood

Recreation

Shoulder

Anxiety
GENERAL QUESTIONS
Compared to the month before you developed cancer, how would you rate your health-related 
quality of life? (check one box: )

Much better

Somewhat better

About the same 

Somewhat worse

Much worse
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In general, would you say your health-related quality of life during the past 7 days has been: (check 
one box: )

Outstanding

Very good

Good

Fair

Poor

Very poor
Overall quality of life includes not only physical and mental health, but also many other factors, 
such as family, friends, spirituality, or personal leisure activities that are important to your 
enjoyment of life. Considering everything in your life that contributes to your personal well-being, 
rate your overall quality of life during the past 7 days. (Check one box: )

Outstanding

Very good

Good

Fair

Poor

Very poor
Please describe any other issues (medical or nonmedical) that are important to your quality of life 
and have not been adequately addressed by our questions (you may attach additional sheets if 
needed).
Signature____________________________________
Printed name_________________________________
Date________________________________________
APPROVED RPCI IRB
1/5/2024


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Appendix F Patient Instructions
Patient Instructions for Photofrin® and Laser Treatment
You should protect yourself from daylight while in the hospital and when you go home. The 
major danger is severe sunburn of the skin. Photofrin® stays in your body for a long time after 
you have received treatment. Therefore, you must be careful and limit your exposure to daylight. 
You are most likely to be burned by daylight for 6 to 8 weeks after receiving the drug. However, 
you should limit your daylight exposure for about 2 months after the treatment. Several 
suggestions are listed below:
1.
For the first 1 month keep the drapes closed (drawn) so that daylight does 
not enter your room(s) in the hospital and when you go home. You must 
remember that there is a danger from direct sunlight even on days that are 
overcast and cloudy.
2.
Your eyes are also sensitive to direct daylight, so you should wear dark 
sunglasses (100% UV protection) for at least 2 months after receiving 
Photofrin®.
3.
If you must be exposed to daylight, you should wear a hat with a large brim, 
sunglasses, gloves to protect your hands, a long-sleeved shirt or blouse, 
slacks, socks, and a scarf to protect your neckline.
4.
Poor circulation in any area of your body may result in that area retaining 
the Photofrin® for a longer period of time than the rest of your body, 
and this area will need extra protection for a longer time than 2 months.
5.
You may be exposed to indoor light from a low wattage (60 watt) light bulb 
for up to ten hours each day. For longer periods of exposure to light, dimly 
lit rooms are advisable (60 watt). Exposure to Fluorescent lighting is OK. 
You may watch TV and use indirect lights such as the lights in the 
hospital found above your bed, which shine toward the ceiling. Try not 
to use Ultra-violet or Halogen lights.
o
For reading, it would be useful to use a small book lamp (example: Itty-bitty 
Book lamp). The book light will prevent you from having the light shine on you.
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6.
Do not have your eyes examined for at least 2 months after receiving 
Photofrin®. This is a precaution to prevent any retina damage that could 
occur from exposure to the bright exam light used in eye exams.
7.
Please also do not go to the dentist in the 2-month period after receiving 
Photofrin® to prevent any oral/facial skin burning from the bright exam 
light.
8.
Showers and baths are allowed.
9.
You must report any redness, swelling, tenderness, blistering, sunburn, or any 
other event that does not usually happen to you.
10.
Remember that your doctor is here to study the usefulness of Photofrin® 
and photodynamic therapy for the treatment of tumors; your questions, 
concerns, and symptoms are important.
11.
Please help the doctor to learn more about you and your treatment by 
keeping lists of questions, concerns, and symptoms. Your doctor will 
address these when you see them. Also, remember that the nurse can aid 
you at any time.
12.
You are welcome to bring any family member or close friend to your 
appointments to help you in communicating with your doctor.
APPROVED RPCI IRB
1/5/2024


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Skin Testing After Photofrin®
1. When should I test my skin?
Approximately 1 month after receiving the drug Photofrin®.
2. What do I do?
Cut a hole in a paper bag approximately 2-inch diameter. Place the 
bag over your forearm. Cover all other skin thoroughly. Expose the 2-
inch diameter of the forearm skin to direct sunlight for one minute, 
then examine for evidence of skin reaction, such as redness, blistering 
or burning sensation. If there is no reaction, expose the skin again, 
and check it in another minute. Repeat this procedure up to eight more 
times, provided there is no sign of skin reaction.
3. What if I see a skin reaction?
Immediately cover the exposed skin and stop the skin test. You may retry 
skin testing in a few days. Contact your doctor or nurse to find out more 
information.
4. What if I don’t have a skin reaction?
If there is no reaction after the above procedure, cover the exposed skin 
and protect yourself from sunlight for 24 hours. Re-examine the exposed 
skin at the end of this time. If there is no delayed skin reaction, slowly 
begin to increase your time in direct light.
5. Should I use sunscreen?
No. A sunscreen will not help protect your skin from the sun when using Photofrin®.
APPROVED RPCI IRB
1/5/2024


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Page 61 of 64
Appendix G Tumor response following irRECIST, according to attachment: "irRECIST-
path-PDF Bohnsack et al 2014 ESMO abstract.pdf". 
Target Lesion Selection for irRECIST

Follow the definitions from RECIST 1.1
Non-measurable Lesion Definitions for irRECIST

Follow the definitions from RECIST 1.1
Response
Criteria for Response per irRECIST 
Complete 
Response 
(irCR)
□
irCR: complete disappearance of all measurable and non-measurable lesions. 
Lymph nodes must decrease to < 10 mm in short axis. Confirmation of response is 
not mandatory.
Partial 
Response 
(irPR)
□
irPR: decrease of ≥ 30% in TMTB relative to baseline, non-target lesions are irNN, 
and no unequivocal progression of new non-measurable lesions.
Stable Disease 
(irSD)  
□
irSD: failure to meet criteria for irCR or irPR in the absence of irPD.
(irNN)
□
irNN: no target disease was identified at baseline and at follow-up the patient fails 
to meet criteria for irCR or irPD.
MD/PI/Co-I Signature ___________________________________       Date  ______________________
Printed Name ____________________________________
APPROVED RPCI IRB
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OUTPATIENT PROGRESS RECORD
Protocol Title and Number -
                                                                                                                          Date of Assessment: 
_______________
Response
Criteria for Response 
Progressive 
Disease 
(irPD)
  □
irPD: minimum 20% increase and minimum 5 mm absolute increase in TMTB 
compared to nadir, or irPD for non-target or new non-measurable lesions. 
Confirmation of progression is recommended minimum 4 weeks after the first irPD 
assessment.
Non 
Evaluable 
(irNE) 
□
irNE: used in exceptional cases where insufficient data exists.
No 
Disease 
(irND)
 □
irND: in adjuvant setting when no disease is detected.
MD/PI/Co-I Signature: ____________________________                   Date: ________________
Printed Name ____________________________________
APPROVED RPCI IRB
1/5/2024


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Appendix H NCCN Guidelines Version 1.2018 Follow up Recommendations
APPROVED RPCI IRB
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APPROVED RPCI IRB
1/5/2024

ICF_000.pdf: 
Document Coversheet 
 
  
 
 Study Title:      A Phase 1 Trial: Porfimer Sodium Mediated Interstitial Photodynamic for the 
Treatment of Patients with Locally Advanced or Recurrent Head and Neck Cancer 
 
 
Institution/Site:  
Roswell Park Comprehensive Cancer Center 
Document (Approval/Update) Date: 
12/27/2021 
NCT Number: 
NCT03727061 
IRB Number 
I 67918 
 
 
 
 
 


Protocol #:   
I 67918
Page 1 of 19     
V.8
Participant Name:   
MR#:
Date: 12/27/2021
ROSWELL PARK CANCER INSTITUTE
d/b/a ROSWELL PARK COMPREHENSIVE CANCER CENTER
ELM AND CARLTON STREETS
BUFFALO, NY  14263
Title: A Randomized, Phase 2 Trial with a Phase 1 Safety Run-In: Porfimer Sodium 
Mediated Interstitial Photodynamic Therapy and Standard of Care Therapy versus Standard of 
Care Therapy alone for the Treatment of Patients with Locally Advanced or Recurrent Head and 
Neck Cancer.  
Principal Investigator:  
Kimberly Wooten, MD
Roswell Park Comprehensive Cancer Center
Elm and Carlton Streets
Buffalo, NY 14263
(716) 845-4094
Roswell Park Study Number: I 67918
Consent Form Given to Patient Taking Part in an Investigational/Clinical Research Study 
This is a clinical research study. Clinical research studies include only those patients who choose 
to take part.  Please take your time to make your decision.  Discuss it with your family and with 
people who are important to you. 
We invite you to take part in a clinical research/investigational study for patients with head and 
neck cancer.
It is important that you read and understand several general rules that apply to anyone that takes 
part in our studies:
1. This study is considered research. It is investigational.
2. Taking part in the study is voluntary.
3. You may withdraw from the study at any time without penalty, loss of any benefits or 
access to care at Roswell Park to which you are otherwise entitled.
4. If you should decide not to take part in this study, it will not affect your care at Roswell 
Park now or in the future. 
5. You should feel free to get a second opinion.  This will not affect your ability to receive 
care and treatment here if you get one.  
6. Your disease may not be helped from taking part in this study, but we may get information 
that will help others.
7. If we become aware of important new findings that relate to your participation or continued 
participation in this study we will discuss them with you.
The type of study, the risks, benefits, discomforts, and other important information about this study 
are discussed below.
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 2 of 19     
V.8
Participant Name:   
MR#:
Date: 12/27/2021
CONFLICT OF INTEREST STATEMENT
Dr. Gal Shafirstein, D.Sc. (Co-Investigator) is an inventor of a device (light dosimetry system) 
that will be used in this experimental treatment and for which a patent was filed by the 
institution. If the patent is pursued, based on data from this and other research, royalties and 
other compensation may be received by the institution and the investigator. Thus, Roswell Park 
and the investigator have a financial interest in the outcome of this treatment. Dr. Shafirstein had 
a paid relationship with the provider of the photodynamic therapy drug (Photofrin®), Pinnacle 
Biologics, for serving as a member of their advisory board. The drug company also provides 
drug and research funds to the institution (Roswell Park) for use in research in Dr. Shafirstein’s 
laboratory. 
If you require further information regarding the financial arrangements described in this 
paragraph, you should discuss the matter with the investigator, Dr. Kimberly Wooten, MD at 
phone  number 716-845- 4094.

Any questions regarding financial conflict issues can be directed to your doctor or to 
Donald Handley, Executive Director of Research Subject Protection, who can be reached 
at 716-845-3455.

This disclosure is made so that you can decide if this relationship will affect your 
willingness to participate in this study.
1. INTRODUCTION
You are invited to participate in this study because you were diagnosed with head and neck cancer 
that failed prior treatments, and you are not a candidate for surgery or radiation therapy. To date, 
the U.S. Food and Drug Administration (FDA) approved to treat tumors like yours with 
combination chemotherapy and/or targeted therapy and/or immunotherapy, which we call standard 
of care. Additionally, patient may receive  other clinically approved treatments for the disease 
management that include reirradiation and/or palliative treatment for pain control. However, these 
standard of care therapies are effective in only about 5% to 15% of the cases and have shown to 
help in reducing symptoms (palliation) in no more than 36% of the cases. In this study, the doctors 
assume that they can further improve these cure rates by adding an experimental interstitial 
photodynamic therapy with porfimer sodium (trade name Photofrin®) to the FDA approved 
standard of care. 
PDT consists of injecting a light sensitive drug (photosensitizer, in this study porfimer sodium) 
into your vein, waiting for a period of time (about 48 hrs), and then activating the drug with a laser 
light. Typically the laser light is delivered to the surface of the tumor. However, in the treatment 
of large cancer tumors (like yours) we must deliver the light through laser fibers that are inserted 
into the tumor (interstitially). That type of treatment is called interstitial photodynamic therapy (I-
PDT).
The FDA has approved the use of porfimer sodium with photodynamic therapy (PDT) in the 
treatment of early stage cancer of the lung and esophagus, only. Many, small, clinical studies 
suggest that porfimer sodium with PDT may be beneficial in the treatment of other cancers such 
as: cancer of the head or neck, various types of skin cancer (excluding melanoma), cancer of the 
bladder, prostate cancer, breast cancer, vulvar cancer, pancreatic cancer, biliary cancer, and brain 
cancer. The PDT treatment can be used in combination with surgery and chemotherapy.  
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 3 of 19     
V.8
Participant Name:   
MR#:
Date: 12/27/2021
In addition, few other clinical studies suggest that adding experimental Photofrin® PDT prior to 
or during standard of care chemotherapy has the potential to improve outcomes in patients with 
malignant mesothelioma, advanced esophageal cancer, and for patients with unresectable (cancer 
that cannot be operated on) cholangiocarcinoma, all of whom have no effective standard 
treatments.
2. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this study is to find out if porfimer sodium I-PDT with standard of care is safe and 
effective to treat patients with head and neck cancer that failed prior treatments and are not 
candidate to surgery or radiation therapy. Therefore, in this study the doctors' goals are to find 
answers to the following questions:
1. What is the safest shortest time (between 7(±2) days, 14 (±4) days, or 28 (±4) days) to 
administer porfimer sodium I-PDT prior to standard of care?
2. How effective porfimer sodium I-PDT with standard of care in comparison to standard of 
care alone?
To find an answer to the first question the doctors suggest conducting a small study (Phase 1). In 
this study the doctors will evaluate the safety of I-PDT + standard of care by examining side effects 
as function of the time (0, 2 or 4 weeks) of when the I-PDT will be administered prior to standard 
of care.  
To find an answer to the second question, the doctors suggest conducting a larger study (Phase 2) 
where they will compare the objective tumor response (change in tumor size) between the 
experimental treatment group  (I-PDT + standard of care) and standard of care therapy group. 
3. WHO ELSE WILL BE ON THIS STUDY AND HOW LONG WILL IT LAST?
In the Phase 1 study up to 12 patients will be enrolled and treated by the doctors at the Roswell 
Park Comprehensive Cancer Center. The study is expected to enroll patients for 3 years. You will 
be on the study up to 8 weeks. 
4. WHAT WILL HAPPEN IF YOU ARE ON THE STUDY?  
Prior to being enrolled you will have to undergo a standard diagnostic head and neck scan with 
computed tomography (CT) or magnetic resonance imaging (MRI), as clinically indicated. This 
requirement may be waived if you had such an imaging within 4 weeks prior to entering study, 
and the study team can receive and evaluate those scans. 
Phase 1:

I-PDT with porfimer sodium prior to your schedule standard of care therapy. 

Standard of Care treatment received at either 7(±2) days, 14 (±4) days, or 28 (±4) days 
after I-PDT.
o
If your treating physician believes that your tumor may require more than one 
course of I-PDT for complete and effective illumination, the Standard of care will 
occur at either 7(±2) days, 14 (±4) days, or 28 (±4) days after your last I-PDT 
treatment. 
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The Phase 2 study will begin after the Phase 1 is completed, and the doctors determined the safest 
time to administer the I-PDT prior to standard of care. Phase 2 will be a randomized research study 
that will include up to 70 patients from whom 35 will receive I-PDT + Standard of Care, and the 
other 35 will receive standard of care alone. The doctors at the Roswell Park will treat these 
patients. You will be on the study up to 2 years. The study should be completed within 2-3 years. 
The placement into one of the treatment groups would be random (by chance). Neither you nor 
your doctor can choose the group that you will be placed in. Randomization is a process used to 
place patients in different treatment groups. A statistician will use a computer to assign participants 
to the study groups. By using randomization, the groups will be similar and the treatments they 
receive can be compared objectively. 
You will have same chance of being placed in the I-PDT + standard of care group or in the standard 
of care group alone. At the time of this study, it is not known which of the treatments is better.
The standard of care treatment will be determined and managed by your Oncologist who will 
choose the most appropriate FDA approved treatment for you and your disease. The standard of 
care therapies may include chemotherapy and/or targeted therapy and/or immunotherapy.
Phase 2 you will receive EITHER:

I-PDT with standard of care therapy 
OR

Standard of Care treatment only
For either treatment you are randomized to you will be asked to do the following:

Visit the clinic at approximately 6-8 weeks, and every 3-4 months for year one, and every 
4-6 months for year 2, as part of the study. 

Complete a quality-of-life questionnaire prior to treatment and during clinic visits. 

Allow Roswell Park to follow up on your medical condition for 5 years to look at the long-
term effects of the treatment/procedure you will receive on the study.
5. IF YOU TAKE PART IN THIS STUDY, WHAT TESTS AND PROCEDURES WILL 
YOU HAVE DONE?  
The doctor will discuss the use of the devices with you and their potential benefits and risks. A 
brief summary of the experimental treatment may be provided to the company (Pinnacle 
Biologics, Inc.) to document the use of the dosimetry (measurement) system with the use of the 
drug and laser.  Information the manufacturer may receive about your experimental treatment 
will contain no information to identify you as an individual. 
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Which test/procedures (or combination) are considered investigational?
Procedure/Tests
Where will this be performed? 
Inpatient Or Outpatient
When?
Computer based 
treatment planning 
Research laboratory 
About 3 -28 days prior to the I-PDT
Quality of Life 
Questionnaire
Outpatient or may complete this 
at home
Before treatment, at 6-8 weeks and 
every 3-4 months in the first year post 
treatment, and every 6 months up to 24 
months after treatment. 
Insertion of sharp 
closed-end sterile 
catheters into the 
tumor and treatment 
region
In the operating room 
Before light treatment 
Experimental laser 
systems
In the operating room
During light treatment
Treatment laser fibers 
In the operating room
During light treatment
Measurement of light 
dose (part of the 
dosimetry system)
In the operating room 
During light treatment 
Use of light detectors 
(part of the dosimetry 
system)
In the operating room 
During light treatment
I-PDT
In the operating room
Outpatient or Inpatient, may be 
kept for observation
4-24 hours dependent on size of tumor 
and whether you will be observed for 24 
hours
CT or MRI, as 
clinically indicated
Outpatient
Within 4 weeks before I-PDT.
Use of surface markers
Outpatient
During CT or MR imaging
Within 4 weeks before I-PDT
Ultrasound imaging
In the operating room
Before catheters insertion
porfimer sodium 
(Photofrin®) injection
Outpatient
48 ± 8 hours before the light treatment; 
you will receive one injection only
The I-PDT with porfimer sodium experimental treatment includes the following steps:

You will undergo a standard diagnostic head and neck scan with CT or MRI. The 
doctors, nurse or imaging technician, will place surface markers (temporary stickers) on 
your skin at the region of the tumor, a few minutes before the imaging. These stickers 
(about 3-5 mm in diameter) will assist the research team in the planning of the I-PDT. 
The stickers may be replaced with small points (2-3 mm) of a temporary ink marker. The 
sticker and ink markers will be removed few minutes before the light treatment. They are 
not harmful and will leave no permanent mark.  
o
If you had a CT or MRI that was obtained within 8 weeks prior to I-PDT, and the 
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study team can receive the scan for evaluation, then the study team will use that 
scan and no markers will be placed. 

The scans will be de-identified by removing all your personal details and replacing them 
with a code that relates to you. The de-identified scans will be sent to Dr. Shafirstein’s 
research laboratory at Roswell Park. Working with your treating physician, Dr. 
Shafirstein’s research team will use a computer code (developed in his laboratory) to 
generate images and calculate how the laser light will illuminate your tumor.  This plan 
will assist your treating physician to decide if I-PDT can be used to treat your tumor. 
If your treating physician decides that your tumor can be treated with I-PDT with 
porfimer sodium, you will receive the following procedures:  

You will receive one dose of porfimer sodium (at 2 mg/kg of your body weight) 
about 48±8 hours before your scheduled experimental treatment with I-PDT. The 
porfimer sodium will be in a liquid that will be slowly injected into one of your veins, 
over 3-5 minutes.

You will have a research blood drawn (approximately 2 teaspoons) prior to the 
injection of porfimer sodium.

You will return to Roswell Park for the I-PDT treatment that will take place in the 
surgery room, while you are asleep.  

The physician will use the computer-based treatment plan as guidance for inserting the 
catheters to treat you with I-PDT. Note, the treating physician will make the final 
decision of how many catheters will be inserted and where they should be inserted, 
considering your safety and the objective to deliver an I-PDT that is most likely to be 
effective.  

An ultrasound system will be used, prior to catheter insertion, to confirm that the 
catheters can be safely placed, according to the plan. The catheters will be used to 
accommodate the laser fibers that will deliver the therapeutic light. 

If possible, an intraoperative CT (or other clinically approved imaging) will be used to 
image the catheters in the tumor. 

Laser treatment fibers with cylindrical end will be inserted into the close-end catheters. 
Only one laser fiber will be inserted into each catheter. 

Additionally, dosimetry (measurement) fibers to measure the laser light will be inserted 
into other catheters. 

The laser fibers will be connected to laser systems that will be used to deliver the 
therapeutic light into the tumor. In the event that the treating physician feels that there 
is a need to treat the superficial surface of your tumor, the treating physician  will use 
a laser fiber (like flashlight)  to illuminate the surface of your tumor. That will add 
approximately 6-9 minutes to  the treatment.

A light dosimetry system will be used to monitor the light during I-PDT. The laser 
treatment and dosimetry fibers could be moved from one catheter to another.

At the end of I-PDT, the lasers will be turned off and all the catheters and fibers will 
be removed.
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The effect that the treatment is having on your cancer will be closely monitored and the 
continuation of your treatment will be determined by how well the cancer is being controlled. The 
status of your tumor will be re-evaluated with physical examinations and biopsies. The status of 
your tumor will be re-evaluated at 6-8 weeks, 12-16 weeks and then at the discretion of your 
physician. You will continue to be checked every 3-12 months (physical exams and biopsies, if 
needed) indefinitely after you have finished the treatment as this is routine standard of care follow-
up schedule after cancer treatment.
IF YOU DO RECEIVE THE EXPERIMENTAL TREATMENT, WHAT TESTS AND 
PROCEDURES WILL YOU HAVE DONE?
It is most likely that a single session (or course) of the I-PDT will be required to treat your tumor. 
However, if your treating physician believes that your tumor may require more than one course of 
I-PDT for complete and effective illumination, up to three sessions of I-PDT may be conducted at 
least 30 days apart.  In each session you will receive the same dose of the drug (porfimer sodium 
at 2 mg/kg).  
The schedule listed below will be followed in each I-PDT course. 

Day One: The study drug, porfimer sodium will be given through a vein in your arm, 
over 3-5 minutes. You will be an outpatient. 

Because this drug will make your skin sensitive to sunlight and bright indoor light, 
care will be taken to shield your skin from light while you are in the clinic. You 
should protect yourself from sunlight for at least 30 days after the porfimer sodium 
is given so that the photosensitizer in your skin is not activated. Failure to protect 
yourself from sunlight during this time may result in a severe sunburn type of 
reaction (sunburn may include redness, swelling, pain and blistering in area exposed 
to the sun) on your skin (See Risks section for detailed information).

Day Three: You will have a research blood draw (approximately 2 teaspoons) 

The doctors will give you medicine to make you fall asleep (general anesthesia) through 
the entire procedure.

We will shine a light from the laser that will cause the photosensitizer to become active 
and attack your cancer. The light from the laser will be transmitted through one or more 
laser fibers. 

During I-PDT, measurements will be taken with the dosimetry (measurement) system to 
record how much laser light is getting to your cancer. 

After I-PDT, the doctors will wake you up and you will be taken to another room for 
recovery. The doctors estimate that the entire procedure will be completed within a few 
hours. 

During your care in the clinic or hospital, the use of a pulse oximeter (this checks your 
oxygen level by placing a small clip onto your finger) may be used as part of normal 
standard care. This pulse oximeter has a small light that shines on the fingernail and 
could cause a small burn if it not changed every 15 minutes. The site used for the pulse 
oximeter will be changed frequently to avoid any burn.
Post I-PDT Treatment(s):

After receiving the porfimer sodium you must observe precautions to avoid 
exposure of skin and eyes to direct sunlight or bright indoor light (from examination 
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lamps, including dental lamps, operating room lamps, unshaded light bulbs at close 
proximity, etc.) for at least 30 days. We will provide you with dark sunglasses that 
you should wear for at least 60 days. Some patients may remain photosensitive for 
up to 90 days or more. The photosensitivity (being sensitive to light) is due to 
residual drug, which will be present in all parts of your skin. 

Exposure of the skin to ambient (surrounding on all sides) indoor light is, however, 
beneficial because the remaining drug will be inactivated gradually and safely through a 
controlled reaction. 

You should not stay in a darkened room during this period and we encourage you to 
expose your skin to ambient indoor light. 

After 4 weeks, you should test your photosensitivity by exposing a small area of the skin 
to sunlight for one minute. 

If no reaction (that is no redness or minor burn) occurs within 24 hours, you can 
gradually resume normal outdoor activities, initially continuing to exercise caution and 
gradually allowing increase exposure to sunlight. If some photosensitivity reaction occurs 
with the limited skin test, you should continue precautions for another week before 
retesting. 

The tissue around the eyes may be more sensitive, and therefore it is not recommended 
that the face be used for this testing. If you travel to a different geographical area with 
greater sunshine, you should retest the level of photosensitivity. 

Please note that conventional sunscreens will be of no value in protecting your skin 
against this type of photosensitivity.
6. WHY WOULD YOU BE TAKEN OFF THE STUDY EARLY?  
You may be taken off the study for any of the following reasons:

Your medical condition changes.

New information becomes known to us that would influence your decision to remain on  
the study.

The treatment is no longer helpful to you. Other options for your condition will then be 
discussed with you.  

The sponsor of the study may decide to stop or change the study. 

You do not follow the study schedule or requirements.

You experience unacceptable side effects.

You no longer want to participate.
7. MUST YOU TAKE PART IN OR STAY ON THE STUDY?
Taking part in this study is voluntary.  You may decide not to enter the study or may leave the 
study at any time.  Leaving the study will not result in any penalty or loss of benefits to which 
you are entitled.  However, if you decide to stop being in the study, we encourage you to talk 
with your doctor first about such a choice, so that you are informed about any effects that might 
have on your health and to discuss stopping study participation.
It may be necessary to contact you at a future date regarding new information about the medication 
or procedures that you have received. For this reason, we ask that you notify the Patient Access 
office at 716-845-1049 or stop at the Registration Desk in the Lobby of Roswell Park to update us 
of any change in your address.
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After the procedure, you may be asked questions about your experience with the investigational 
products and may be asked to cooperate in having laboratory tests and physical examinations your 
doctor considers necessary. You can refuse these requests without any penalty. Your refusal will 
not affect you current or future medical care and you will not forfeit any benefits for which you 
are entitled.
8.  WHAT RISKS AND DISCOMFORTS ARE INVOLVED?
The specific risks of using the experimental devices are unknown. It is not anticipated that there 
will be any increased risk of using these devices over the standard PDT. However, all 
investigational products may involve unknown risks and unforeseen adverse reactions, including 
both temporary and permanent side effects. We do not yet know the side effects the use of the 
devices may cause. There may be unknown and unexpected side effects as a result of using these 
devices together.
PDT risks:
Pain
You may experience mild to severe pain for several days to weeks after I-PDT experimental 
treatment/surgery. The physicians will prescribe pain medications before you are discharged 
from the hospital.
Skin Photosensitivity
It is very important that you avoid bright light immediately after you receive the drug porfimer 
sodium. Porfimer sodium makes you extremely sensitive to bright lights for at least 30 days and 
for some patients (rare) this may last for up to 90 days or more.  Bright lights include direct 
sunlight, bright indoor lights such as halogen or spotlights, examining lights such as those used 
by a dentist and intensive light such as that used in tanning salons. Exposure to direct sunlight or 
intense bright light will result in serious sunburn so you must take precautions to avoid exposing 
your skin and eyes to strong direct light. 
Therefore, after receiving the porfimer sodium you must observe the following guidelines and 
precautions:

Avoid exposure of skin and eyes to direct sunlight or bright indoor light (from 
examination lamps, including dental lamps, operating room lamps, and unshaded light 
bulbs at close proximity, for at least 30 days. 

You should also avoid eye examinations with bright lights for at least 30 days after the 
injection of porfimer sodium. 

Please note that conventional sunscreens will NOT protect your skin against this type of 
photosensitivity. 

You should wear dark sunglasses (that we will provide you with) for at least 60 days. 

You must wear protective clothing, including a hat, gloves, sunglasses, long sleeves and 
pants whenever you are outdoors in bright sunlight. This protective clothing is necessary 
for at least 30 days after the injection of porfimer sodium.

At home you must draw the drapes or blinds on windows that admit bright, direct 
sunlight during the day.

Some patients may remain photosensitive for up to 90 days or more. The photosensitivity 
(being sensitive to light) is due to residual drug, which will be present in all parts of your 
skin. 
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
You should not stay in a darkened room during this period and we encourage you to 
expose your skin to ambient (surrounding on all sides) indoor light. 

After 4 weeks, you should test your photosensitivity by exposing a small area of the skin 
to sunlight for 10 minutes. If no reaction (that is no redness or minor burn) occurs within 
24 hours, you can gradually resume normal outdoor activities, initially continuing to 
exercise caution and gradually allowing increased exposure to sunlight. If some 
photosensitivity reaction occurs with the limited skin test, you should continue 
precautions for another week before retesting. The tissue around the eyes may be more 
sensitive, and therefore it is not recommended that the face be used for this testing. If you 
travel to a different geographical area with greater sunshine, you should retest the level of 
photosensitivity.
If you do not follow the precautions about avoiding strong, direct light you may suffer severe 
sunburn, even after exposure to sunlight for just a few minutes. This sunburn can be more severe 
than sunburns you may have received in the summer or in hot climates.  It happens after a much 
shorter exposure to direct sunlight. If a photosensitivity reaction does happen to you, it will 
usually get better after about 10-14 days. If it is very severe, you may require treatment to reduce 
the swelling and discomfort. It is important to report any photosensitivity reactions to your 
doctor.
Some people have noticed a slight, but permanent, darkening of the skin exposed to sunlight. 
Photosensitivity reactions after treatment with porfimer sodium have been observed in 
approximately 10-15% of patients and were mostly mild, with redness and rarely mild swelling. 
All symptoms resolved without any lasting effect. Typically these reactions were mostly mild to 
moderate erythema (redness of skin) but also included swelling, itching, burning sensations, 
feeling hot, or blisters.
Porfimer Sodium Risks
Likely Side Effects: Those that occur in approximately 15%–30% of persons who receive this 
drug.

Anemia

Fever

Constipation

Nausea

Chest pain

Pain

Abdominal pain

Shortness of breath

Photosensitivity reaction 

The formation of blisters from sunburn

Sensitivity of eyes to bright lights

Pneumonia

Vomiting
Less Likely Side Effects: Those that occur in approximately 10%-14% of persons who receive 
this drug.

Redness from sun exposure or from bright lights

Unable to sleep
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
Back Pain

Sore throat

Difficulty swallowing

Abnormal heart rhythm

Lungs cannot take in enough oxygen
Unlikely Side Effects: Those that occur in approximately 5%-9% of persons who receive this 
drug.

Fungal infection of the mouth

Weight loss

Confused state

Tumor bleeding

Anorexia

Esophagus swelling/irritation

Vomiting of blood

Low blood pressure

Cough

Anxiety

Dehydration

Urinary tract infection

Swelling of tissues, usually in the lower limbs, due to the accumulation of fluids

Cardiac failure

Abnormally fast resting heart rate

Upset stomach

Narrowing of esophagus

Weakness

High blood pressure

Chest pain

General swelling (edema)

Blood in stools 

Belching

Diarrhea
Rare but Serious Side Effects: Those that occur in less than 5% of persons who receive this 
drug.

Rash and itching on skin
Interstitial Photodynamic Therapy (drug and light):
During treatment, the doctor will insert metal needles into your tumor. Such a procedure is 
routinely used for other treatments (such as taking a tissue sample from a tumor) and has 
been associated with the following risks.
Likely Side Effects: Those that occur in approximately 15% - 30% of persons who undergo this 
procedure.

Pain in the treated area

Swelling in the treated area
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
Bleeding within or near the tumor site after PDT
Less Likely Side Effects: Those that occur in approximately 10–14% of persons who undergo 
this procedure.

Difficulty in swallowing (dysphagia)

Transient inflammatory reactions that can be seen as fever, difficulty breathing and 
chest pain.

Weight loss
Unlikely Side Effects: Those that occur in approximately 5%-9% of persons who undergo this 
procedure.

General edema (swelling)

Infection in specific areas within or near treated region

The formation of an ulcer in the mouth
Rare but Serious Side Effects: Those that occur in less than 5% of persons who undergo this 
procedure.

Bleeding within or near tumor site after PDT

Infection in specific areas within or near treated region

Injury to a blood vessel or another organ

Difficulty breathing requiring tracheostomy

There is a chance that tiny parts of the tumor (cancer cells) will be moved from their 
original location during the insertion and removal of the catheters.

Death
In addition, the following complications (with no known statistics) could occur: formation of scar, 
formation of a pocket of clear fluid in your mouth, an opening between a salivary duct or gland 
and the oral cavity (oral fistula), inflammation of a salivary gland, formation of dead tissue in the 
mouth or skin, nerve damage, numbness.
9. REPRODUCTIVE RISKS:
This study may involve risks to you or your unborn child that are not known at this time therefore, 
you should not become pregnant or father a baby while you are participating in this study.  Also, 
you should not nurse your baby while on this study.  Women of childbearing potential will be 
required to take a pregnancy test before being allowed to take part in this study.  You may also be 
asked to take pregnancy tests while receiving the study treatment. The pregnancy test must be 
negative before you enter this study.
You will be asked to practice an effective method of birth control while you are on this study and 
for a time after your treatment ends. This includes, but is not limited to, oral birth control pills, an 
IUD, condoms with spermicide, or abstinence. In women of childbearing potential, birth control 
should continue for six (6) months after the last treatment to ensure the drug/treatment has cleared 
from the body.  Since interactions between the study drug and oral birth control pills cannot be 
ruled out, a “barrier” method of contraception (condom, diaphragm) must be used as well. 
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In certain cases, oral birth control pills cannot be used for birth control.  Please discuss this with 
your doctor.
When you sign this consent form, to the best of your knowledge, you are not pregnant and do not 
plan to become pregnant while taking part in this study.  Should you become pregnant during this 
study, you need to immediately tell your study doctor and obstetrician.  If you wish you may 
request a referral for counseling or ask about counseling (such as genetic counselor, social worker, 
or psychologist.) to discuss this further.  
Male patients must use an effective method of birth control.  This can include, but is not limited 
to, condoms with spermicide, abstinence, or having a vasectomy.  When taking part in this study, 
you should continue use of birth control for three months after receiving the last dose of the drug 
to be sure the drug has cleared from the body.  Males who are receiving treatment should not 
donate sperm for at least three months after the study is completed. Discuss birth control measures 
with your doctor.  
10.  WHAT BENEFITS MAY YOU GET FROM THIS STUDY? 
It is not known if this treatment will help you or not.  If the treatment is successful, you might see 
a decrease in your symptoms and improvement in your quality of life. It is also possible the 
investigational treatments may prove to be less useful or even harmful to you. You understand that 
there is no guarantee that being on the study will help you.  Future patients may be helped from 
the results and information gained from this study.
11. WHAT IF YOU DO NOT JOIN THIS STUDY?
If you do not join this study, you should discuss the options with your doctor.  They may include: 
1. Usual/standard treatment for your disease or condition may be appropriate.  This may 
include treatment with other drugs, drug combinations, or possibly other research programs 
here or at other centers which may be testing new drugs for your type of cancer.   
2. No treatment, but medications and measures to keep you comfortable. This is sometimes 
called supportive care.
Feel free to talk with your health care team about your disease and your treatment choices.
12. WHAT WILL THIS COST? 
Examinations, scans, laboratory tests, and other medical procedures and treatments that would 
routinely be needed to monitor and treat your illness are known as “standard of care” services. 
Charges for these services will be billed to you and/or your insurance carrier in the usual manner. 
You will be responsible for all co-payments, deductibles, and/or account balances as determined 
by your individual health insurance contract.
There are many different types of insurance plans and contracts.  It is not possible to tell you in 
advance the exact amount your insurance will pay and what your financial responsibility will 
be.  If you wish, a financial counselor can meet with you to help answer your questions regarding 
insurance coverage issues before you decide to participate in this study.  A Financial Counselor 
can be reached at 716-845-3161.
There are certain insurance plans that will not cover charges for any care related to an 
experimental or investigational therapy or study. These plans may deny coverage for even the 
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routine, standard of care medical services you will need to receive during the time you are 
enrolled in the study.  If you have an insurance plan that does not cover participation in a clinical 
research study, or if you currently have no insurance coverage, a financial counselor can meet 
with you to provide an estimate of the costs that would be associated with participation in this 
study.  A payment schedule can be developed if needed.  A Financial Counselor can be reached 
at 716-845-3161.
A representative from the Patient Access Department can help you obtain authorizations from 
your insurance carrier when needed.  A representative from the Patient Access Department can 
be reached at 716-845-1049.
Examinations, scans, laboratory tests and other medical procedures and treatment that are 
required only for the clinical research study and are not needed for the usual care of a patient 
with your disease are known as “research related” services.  Research related services will not be 
charged to you or your insurance.  
The following experimental procedures and devices that you will receive as part of your 
clinical research study are considered research related: Dosimetry System, lasers, fibers 
and all devices used to administer the I-PDT. 
In addition, the drug porfimer sodium (Photofrin®) will be provided to you at no cost, as 
part of the study.  
You and /or your insurance company will be responsible for charges related to the administration 
of drugs used in this clinical research study and for charges for medications that may be needed 
to prevent or control side effects.
If you develop complications or side effects from your participation in this clinical research study, 
medical treatment will be provided at the usual charge.  A financial counselor can be reached at 
716-845-3161 to provide an explanation of coverage and to answer questions you may have 
regarding study related billing.
13.  WHAT HAPPENS IF YOU ARE INJURED AS A RESULT OF THIS STUDY?
If you believe you have been injured as a direct result of your participation in this research study, 
notify the Roswell Park Patient Advocate at (716) 845-1365 or the Study Doctor at (716) 716-
845-4898.
Medical diagnosis and treatment for the injury will be offered, and a determination will be made 
regarding appropriate billing for the diagnosis and treatment of the injury.  A financial counselor 
can be reached at 716-845-3161 to provide an explanation of coverage and to answer questions 
you may have regarding study related billing.
You do not give up any legal rights by signing this form.  You are not prevented from seeking to 
collect compensation for injury related to malpractice, fault, or blame on the part of those 
involved in the research.
14.  WILL YOU BE PAID FOR JOINING THIS STUDY? 
You will receive no payment for taking part in this study. 
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 15 of 19     
V.8
Participant Name:   
MR#:
Date: 12/27/2021
It is possible that this research project will result in developing treatments, devices, new drugs, or 
procedures. If this happens, you understand that you will not receive any financial payment from 
the resulting use of information gained and developed through your participation in the research 
study.  
15. WHAT IF YOU HAVE QUESTIONS?
You are free to ask questions at any time about this study and to ask for more information from 
the doctor identified on this consent. If you have any questions, concerns or complaints about this 
study, you should contact Dr. Kimberly Wooten, MD at 716-845-2300 or 716-845-4094, at 
Roswell Park. In case of an emergency after regular hospital hours, you should telephone (716) 
845-2300 and ask for the oncologist on call who if need to will be able to contact study primary 
investigator, Dr. Kimberly Wooten, MD or representative. 
If you have questions about your rights as a research subject or you feel you have been injured as 
a result of your participation in this research study, you can call the Roswell Park Patient Advocate 
(Support) Office at (716) 845-1365.  You should also feel free to contact the Patient Advocate 
Office at any time while considering participation, during participation or once your participation 
is complete.  This office is unaffiliated with any specific research study.  They can help you obtain 
additional information regarding your research participation and your rights as a research subject 
or how to proceed should you feel you have been injured as a result of your participation.  They 
are available to discuss any problems, concerns, questions or input you may have.
Where can I find more information?
You may call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results. You can search this Web site at any time.
For 
accurate 
cancer 
information 
including 
Physician 
Data 
Query 
(PDQ), 
visit 
https://www.cancer.gov. PDQ is NCI’s comprehensive cancer database.  It contains summaries on 
a wide range of cancer topics; a registry of open and closed clinical trials from around the world; 
and a directory of professionals who provide genetic services.
16.  WHAT ABOUT CONFIDENTIALITY AND USE OF PROTECTED HEALTH 
INFORMATION?
If you volunteer to take part in this research study, and you sign this document, you give 
permission to the following providers to use or disclose (release) your health information that 
identifies you as part of the research study described in this consent.  This means that others may 
know or be able to find out your identity.

Dr. Wooten and members of her research team

Government or Regulating Agencies such as the FDA or other agencies worldwide

Institutional Review Boards or Data Safety and Monitoring Boards at Roswell Park and 
its’ affiliates
If you volunteer to take part in this research study, you consent to the release of your health 
information from other medical facilities for any moderate to life-threatening or fatal adverse 
events that occur while on study treatment through 30 days after treatment ends.
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 16 of 19     
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Participant Name:   
MR#:
Date: 12/27/2021
Study information that we may use and/or disclose can identify you in the following ways:
“Protected Health Information” (PHI) can be your name; address, patient identification number; 
medical record number; date of birth; photographs; information about your health, including past 
medical history, treatment, diagnosis, test results and any other information about your health or 
medical condition; or about payment of charges for medical treatment found in your medical 
record or other records maintained by Roswell Park. 
This study includes a number of researchers, businesses and government agencies.  They may 
use your health information and share it with others.  We want you to know who may use this 
information and how they may use it. We also want to tell you about your rights before you 
agree to take part in this study.
Who may use and give out information about you?
The study doctor and research staff will have this information and may give it to others during 
and after the study.
Who may see this information?  
The study sponsor may also see this information. The “Sponsor” includes all people or 
companies working for or with the sponsor or owned by the sponsor.  They all have the right to 
see this information during and after the study.
The following people, agencies and businesses may also get information about you: 

Doctors and healthcare professionals at Roswell Park 

The referring doctor

US Food and Drug Administration (FDA)

US Department of Health and Human Services (DHHS)

Other federal and state agencies such as the Office of Human Research Protections, 
(OHRP), Office of Biotechnology Activities (OBA) and the NYS Department of Health

National Cancer Institute (NCI)

National Institute of Health (NIH)

Government agencies in other countries

Government agencies that must receive reports about certain diseases and conditions  

Institutional Review Board at Roswell Park and/or their affiliates

Pinnacle Biologics, Chicago, IL, USA
 What information may be used and shared?
Medical information that identified you and relates to your participation will be created if you 
take part in this study.  This may include the following:

Information from the procedures used to find out whether you are eligible to take part in 
this study.  This may include physical examinations, blood and urine tests, x-rays and 
other procedures or tests, and any other information that you may release to us, including 
information about your health history.

Information obtained in the course of the study including information about your 
response to any treatments you receive, information related to study visits and phone 
calls, physical examinations, blood and urine tests, x-rays and other procedures or tests, 
and any other information about your participation in this study.
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 17 of 19     
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Participant Name:   
MR#:
Date: 12/27/2021
Why will this information be used and/or shared?
The information that may identify you will be used and given out to others to carry out the 
research study.  The sponsor will analyze (test) and evaluate the results of the study.  The 
sponsor, its agents, government agencies, and others may visit the research site to follow how the 
study is being done and may review your information for this purpose.
This information may be given to the FDA.  It may also be shared with other governmental 
agencies in this country and in other countries.  This is done for participant protection and so the 
sponsor can receive marketing approval for any new products that may result from this research.  
The information may also be used to meet the reporting needs of the governmental agencies.
The results of this research may be published in scientific journals or presented at medical 
meetings, but your identity will not be disclosed (shared).
The information may be reviewed by the IRB at Roswell Park and its affiliates, who perform 
review of research as needed by law.
PHI may be used and disclosed in the creation and maintenance of a research database or 
repository.  This information may then be used for other research, either de-identified or with 
further IRB review and approval. This information can be kept indefinitely.
What if I decide not to give permission to use and give out my health information? 
If you refuse authorization for us to use and disclose your information as indicated above, you 
will not be able to be in this research study.
Your decision not to sign this authorization or to withdraw from the study will not involve any 
penalty or loss of benefits to which you are otherwise entitled and will not affect your access to 
non-research related health care here.
You may change your mind and revoke (take back) this authorization at any time, except to the 
extent that Roswell Park has already acted (used or disclosed PHI) based on this authorization. 
What happens if I want to withdraw my authorization?
To revoke/withdraw this authorization, you must write to the study doctor (whole name is on the 
first page of this form) and let the doctor know that you are withdrawing your authorization to 
use and disclose your information.  The doctor’s mailing address is: 
Kimberly Wooten, MD 
Roswell Park Comprehensive Cancer Center,
Elm & Carlton Streets,
Buffalo, New York 14263
If you should die while enrolled in or after taking part in this study, your PHI may be used or 
disclosed solely for research purposes without getting any added authorization.
The results of clinical tests or therapy performed as part of the research may be included in your 
medical record and will not be removed from the record if you withdraw.
If all information that does or can identify you is removed from your health information, the 
remaining information will no longer be subject to this authorization and may be used or 
disclosed for other purposes.
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 18 of 19     
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Participant Name:   
MR#:
Date: 12/27/2021
May I review or copy the information obtained from me or created about me? 
You will not have the right to review or copy aspects of your Protected Health Information (PHI) 
that are considered to impact the integrity (truthfulness) of this research study. At the end of this 
research study and at your written request, you may have access to your health information that 
relates to the research study. This information is kept in your medical record, which is a set of 
data that includes medical information or billing records used in whole or in part by your doctors 
or other health care providers at Roswell Park to decide about care and treatment. Access to your 
health information in your medical record is described in the Notice of Privacy Practices 
provided to you by Roswell Park.  If it is necessary for your care and/or treatment, your PHI will 
be provided to you or your referring or primary care doctor.  You will not have access to your 
blood, tissue, and diagnostic research study results that are performed in a laboratory/facility that 
is not approved to report clinical results.
If it is necessary for your care and/or treatment, your PHI will be provided to you or your 
referring or primary care doctor.  
When does this authorization end?  
This authorization does not have an end date.   
What happens to my health information after it is given to others? 
If you sign this form, and the information is given to other people, businesses, or government 
agencies, the information may no longer be protected.  There is a risk that your information will 
be given to others without your permission.
Authorization
As a participant in this study, you allow the use of protected health information for research 
purposes.  You understand that PHI will be used/disclosed by Roswell Park as indicated in this 
document.  You understand that you have a right to withdraw your authorization for use of PHI 
in writing, but that information which has already been used or disclosed before your written 
withdrawal will continue to be used for research purposes.  Finally, you understand PHI that has 
been disclosed by Roswell Park through this authorization to the study sponsor, FDA, NCI, NIH, 
or others may be further disclosed by them, as the PHI will no longer be protected by the federal 
privacy laws.
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023


Protocol #:   
I 67918
Page 19 of 19     
V.8
Participant Name:   
MR#:
Date: 12/27/2021
Statement of Investigator/Person Conducting the Informed Consent Discussion:
I certify that the nature and purpose, the potential benefits and possible risks associated with 
participation in this research study have been explained and that any questions about this 
information have been answered.  A signed copy of this consent will be given to the participant.
SIGNATURE__________________________ DATE__________ TIME______
   
PRINTED NAME ________________________
Participant's Statement of Consent:
By signing below, you agree that:

You have been told of the reasons for this study.

You have had the study explained to you.

You have had all of your questions answered, including those about areas you did not 
understand, to your satisfaction.

You have carefully read this consent form and will receive a copy of this form.

You do not waive any legal rights you have under federal or state laws and regulations.

You willingly give your consent to voluntarily join in this research study.
Participant: 
SIGNATURE________________________________ DATE__________ TIME______
PRINTED NAME ________________________
Witness Signature is needed in the following circumstances-check below:
Not applicable  
The person consenting cannot write – mark must be made as appropriate. 
The person consenting cannot read - consent has been read to him/her.
The person consenting cannot understand English and the consent has been verbally 
interpreted.
(the witness should be fluent in both English and the language of the person consenting.)
Witness Statement:  
The person consenting has signed this document in my presence.
SIGNATURE________________________DATE___________ TIME______
PRINTED NAME ___________________________
RELATIONSHIP TO PARTICIPANT__________________
CONSENT HANDLING
Original to CRA-Regulatory with Race/ 
Ethnicity if applicable
Copy to: 

Patient

Medical Records
APPROVED RPCCC IRB
8/11/2022 TO 8/20/2023