Clinical trial NCT00470496: Photodynamic Therapy Using HPPH in Treating Patients Undergoing Surgery for Primary or Recurrent Head and Neck Cancer
Official title: A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable, Primary or Recurrent Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Basal Cell Carcinoma of the Lip
Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Recurrent Lymphoepithelioma of the Nasopharynx
Recurrent Lymphoepithelioma of the Oropharynx
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Thyroid Cancer
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage I Adenoid Cystic Carcinoma of the Oral Cavity
Stage I Basal Cell Carcinoma of the Lip
Stage I Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Stage I Follicular Thyroid Cancer
Stage I Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Stage I Lymphoepithelioma of the Nasopharynx
Stage I Lymphoepithelioma of the Oropharynx
Stage I Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
Stage I Mucoepidermoid Carcinoma of the Oral Cavity
Stage I Papillary Thyroid Cancer
Stage I Salivary Gland Cancer
Stage I Squamous Cell Carcinoma of the Hypopharynx
Stage I Squamous Cell Carcinoma of the Larynx
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Squamous Cell Carcinoma of the Oropharynx
Stage I Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage I Verrucous Carcinoma of the Larynx
Stage I Verrucous Carcinoma of the Oral Cavity
Stage II Adenoid Cystic Carcinoma of the Oral Cavity
Stage II Basal Cell Carcinoma of the Lip
Stage II Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Stage II Follicular Thyroid Cancer
Stage II Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Stage II Lymphoepithelioma of the Nasopharynx
Stage II Lymphoepithelioma of the Oropharynx
Stage II Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
Stage II Mucoepidermoid Carcinoma of the Oral Cavity
Stage II Papillary Thyroid Cancer
Stage II Salivary Gland Cancer
Stage II Squamous Cell Carcinoma of the Hypopharynx
Stage II Squamous Cell Carcinoma of the Larynx
Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage II Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage II Verrucous Carcinoma of the Larynx
Stage II Verrucous Carcinoma of the Oral Cavity
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 15
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 using HPPH in treating patients who are undergoing surgery for primary or recurrent head and neck cancer. Photodynamic therapy (PDT) uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any tumor cells that remain after surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Identifying the maximum tolerated dose (MTD) of PDT among 4 investigated light dose levels (30, 50, 60 and 75) in combination with surgery in patients with recurrent or primary head and neck cancers.

SECONDARY OBJECTIVES:

I. To make initial observations of efficacy (i.e., tumor recurrence rate) of adjuvant PDT in these patients.

II. To determine the HPPH uptake and distribution (when feasible) in recurrent resected specimens.

III. Observe for wound complications.

OUTLINE: This is a dose-escalation study of laser light.

Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients undergo surgery followed by laser light exposure to the entire tumor bed on day 2.

After the completion of study treatment, patients are followed up at 1 and 3 months and then periodically thereafter at the discretion of the treating physician.

Eligibility criteria: Inclusion Criteria:

* Patients with resectable primary or recurrent head and neck squamous cell carcinomas (HNSCC) who are undergoing surgery to resect the cancer; (operable patients whose disease can be removed surgically with the expectation of clear margins, without compromising vital structures, i.e. respectability is individually determined by the surgeon and is based on anatomic extent of disease as well as technical ability of the operator)
* Female patients must not be pregnant (documented by human chorionic gonadotropin \[HCG\] test) and must be practicing a medically acceptable form of birth control, be sterile or post-menopausal
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must sign an informed consent according to Food and Drug Administration (FDA) guidelines acceptable to the Roswell Park Cancer Institute (RPCI) Institutional Review Board (IRB)
* No radiation therapy, chemotherapy or other biological therapy for at least 30 days prior to PDT

Exclusion Criteria:

* Patients with unresectable tumors
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
* White blood cell (WBC) \< 4,000
* Platelet count \< 100,000
* Prothrombin time 1.5 times above the upper normal limit
* Total serum bilirubin \> 2.0 mg/d
* Serum creatinine \> 2 mg%
* Alkaline phosphatase (hepatic) \> 3 times the upper normal limit
* Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit
* Patients on concurrent chemotherapy or radiation therapy will be excluded
* Patients who have received radiation therapy, chemotherapy or other biological therapy during the past 30 days
* Has not recovered from toxicity of prior therapy

Primary outcomes:
measure: Maximum tolerated dose of photodynamic therapy in which 1 of 6 patients experience dose-limiting toxicity
timeFrame: 30 days
Secondary outcomes:
measure: Time to tumor progression or recurrence
timeFrame: From baseline until objective tumor progression, assessed up to 5 years
measure: Uptake and distribution of HPPH in resected tumor tissue
timeFrame: Day 2
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Hassan Arshad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigual NR, Shafirstein G, Frustino J, Seshadri M, Cooper M, Wilding G, Sullivan MA, Henderson B. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):706-11. doi: 10.1001/jamaoto.2013.3387.