Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease
Conditions
Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Primary Purpose: Treatment
Intervention
Name: porfimer sodium Type: Drug
Name: bronchoscopy Type: Procedure
Overall Status
Recruiting
Summary
RATIONALE: Photodynamic therapy uses a drug 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 effective against non-small cell lung cancer.

PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.
Detailed Description
OBJECTIVES:

Primary

- To test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (PDT) is T cell mediated.

Secondary

- To test the hypothesis that PDT potentially affects survival rates in these patients.

- To test the hypothesis that T lymphocytes mediate an immune response that affects survival in PDT treated patients.

OUTLINE: Patients deemed suitable for photodynamic therapy (PDT) are offered PDT. Patients are divided into 2 groups according to whether or not they receive PDT. All patients are referred to radiation and medical oncology for standard of care adjuvant therapy (beginning after completion of this study).

- Group 1 (PDT): Patients receive porfimer sodium IV over 3-5 minutes and undergo irradiation with red light 48 hours later. Patients receive 2 more treatments at 2-day intervals.

- Group 2 (non-PDT): Patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks.

Blood sample, bronchoalveolar lavage fluid, and tumor tissue are collected after each treatment (group 1) or at time of each bronchoscopy (group 2) and assayed for the presence of lymphocyte phenotypes Th1, Th2, Treg, and Th17. After completion of study therapy, patients are followed at 1 month after PDT and then every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 236 patients (177 undergoing photodynamic therapy [PDT] and 59 not undergoing PDT) will be accrued for this study.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Diagnosis of non-small cell lung cancer

- Any stage disease with obstructive or hemorrhagic endobronchial disease as determined by bronchoscopy

- No existing tracheoesophageal or bronchoesophageal fistulas

- No tumor eroding into a major vessel

PATIENT CHARACTERISTICS:

- No known porphyria or allergy to porphyrins

PRIOR CONCURRENT THERAPY:

- See disease characteristics

- No prior photodynamic therapy, chemotherapy, or radiotherapy

- No concurrent antioxidant therapy or dietary supplements

- Not initiating chemotherapy or radiotherapy during the study time (1 month post diagnostic bronchoscopy)
Location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Susan Moffatt-Bruce, MD, PhD - 866-627-7616
Start Date
December 2008
Sponsors
Ohio State University Comprehensive Cancer Center
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page