Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Non-Small Cell Lung Cancer And Bronchial Disease

Condition(s) targeted: Lung Cancer

Intervention: porfimer sodium (Drug); bronchoscopy (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Ohio State University Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Susan Moffatt-Bruce, MD, PhD, Principal Investigator, Affiliation: Ohio State University Comprehensive Cancer Center

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.

Official title: Immunobiology of Photodynamic Therapy in Lung Cancer Patients

Study design: Allocation: Non-Randomized, Primary Purpose: Treatment

Primary outcome: T cell mediated immune response measured by assays of tumor tissue, bronchoalveolar fluid, and plasma

Secondary outcome:

Survival rates at 6 months and 1 year

Correlation between immune response and survival rates at 6 months and 1 year

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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)

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210-1240, United States; Recruiting
Susan Moffatt-Bruce, MD, PhD, Phone: 866-627-7616

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2008
Last updated: February 2, 2010