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
- 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.
- 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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as measured by NCI CTC v2.0
Daily while in-house, weekly after discharge, at 4-6 weeks and at 6 months
Samjot Dhillon, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|