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A Phase I Study Light Dose for Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-Small Cell Carcinoma in Situ or Non-Small Cell Microinvasive Bronchogenic Carcinoma: A Dose Ranging Study
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.
OBJECTIVES: Primary * To determine the maximally tolerated light dose (MTID) in patients with bronchogenic carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma. * To identify the systemic and normal tissue toxicity resulting from photodynamic therapy using HPPH in these patients. Secondary * To study tumor response in these patients. OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH at that time. After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and periodically thereafter.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
February 1, 2004
Primary Completion Date
June 1, 2013
Completion Date
April 1, 2014
Last Updated
August 4, 2023
17
ACTUAL participants
HPPH
DRUG
Lead Sponsor
Roswell Park Cancer Institute
NCT06066138
NCT07485114
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