Clinical trial NCT01854684: Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
Official title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.

SECONDARY OBJECTIVES:

I. Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.

III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.

IV. To measure temoporfin uptake in malignant and normal tissue.

OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin.

Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT).

After completion of study treatment, patients are followed up every 6 months for 2 years.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer (NSCLC)
* Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2
* 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 6 months after surgery; 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
* The subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
* Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR)

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients with known brain metastases should be excluded from this clinical trial
* Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
* White blood cell (WBC) \< 4,000
* Platelet count \< 100,000
* Total serum bilirubin \> 2 mg/dL
* Serum creatinine \> 2 mg/dL
* Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit
* 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
* Pregnant or nursing female subjects
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
* Received an investigational agent within 30 days prior to enrollment

Primary outcomes:
measure: Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 2 weeks
Secondary outcomes:
measure: Locoregional recurrence-free rate
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: Progression free survival
timeFrame: Up to 2 years
measure: Toxicity rate, using NCI CTCAE version 4
timeFrame: Up to 30 days after completion of study treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Chukwumere Nwogu
role: PRINCIPAL_INVESTIGATOR
References: