Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
RATIONALE: Photodynamic therapy uses light and drugs that make cnacer cells more sensitive to light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic therapy combined with brachytherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy in treating patients with recurrent lung cancer that is blocking the lung passages.
|Lung Cancer||Drug: hematoporphyrin derivative Radiation: brachytherapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Photodynamic Therapy (PDT) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma|
|Study Start Date:||March 1993|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the feasibility, toxicity, and effectiveness of combination therapy with Photofrin PDT and HDT brachytherapy in patients with endobronchial obstructions from lung cancer.
OUTLINE: This is not a randomized study. Photofrin solution is administered slowly as a bolus injection over 3-5 minutes on day 1. Bronchoscopy is performed under general anesthesia 48 hours after Photofrin injection. Light is transmitted from the laser to the tumor via quartz fiber optics (interstitial or surface PDT). Another bronchoscopy is performed 48 hours after PDT treatment to clean out any tissue debris left after PDT treatment. HDR brachytherapy is performed using prescribed dose of radiation for 5-10 minutes to designated positions. Repeat bronchoscopy is performed 3-4 weeks post HDR brachytherapy and a second HDR brachytherapy treatment may be given. Patients are followed every 3 months until death, or for 5 years.
PROJECTED ACCRUAL: 16 patients will be entered over 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014066
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Gregory M. Loewen, DO, FCCP||Roswell Park Cancer Institute|