A Phase I Study of Photodynamic Therapy (PDT) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma
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.
Interventional
Primary Purpose: Treatment
Gregory M. Loewen, DO, FCCP
Study Chair
Roswell Park Cancer Institute
United States: Federal Government
DS 92-40
NCT00014066
March 1993
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |