A Phase I Study of Light Dose for Photodynamic Therapy(PDT) Using 2-[ 1-hexyloxyethel]-2-devinyl Pyropheophorbide-a (HPPH) for Treatment of Non-small Cell Carcinoma in Situ or Non-small Cell Microinvasive Carcinoma. A Dose Ranging Study
I. To determine maximally tolerated light dose (MTID). Identify systemic and normal tissue
toxicity using 2-[hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) for photodynamic
therapy in patients with bronchogenic carcinoma-in-situ (CIS) or microinvasive carcinoma.
I. To study tumor response in patients with bronchogenic carcinoma-in-situ (CIS) or
bronchogenic microinvasive carcinoma.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH intravenously (IV) over 1 hour on day 1. Patients then photodynamic
therapy with laser light on day 3. Patients also undergo therapeutic bronchoscopy for
endoscopic debridement on day 5.
After completion of study treatment, patients are followed up at 4-6 weeks, 6 months, and
then periodically for at least 2 years.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Defined as the dose at which =< 1 out of 6 patients experiences dose-limiting toxicity.
Up to 2 years
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|