A Phase la Trial of Photodynamic Therapy With HPPH (2-1 (Hexyloxyethyl)-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Oral Cavity and/or Oropharynx.
We propose to initiate a Phase 1 a clinical trial using HPPH and 665 nm light in patients
with cancer of the oral cavity and/or oropharynx, including lesions of moderate to severe
dysplasia, squamous carcinoma in situ and T1 squamous cells carcinoma. The study will employ
a fixed HPPH dose of 4 mg/m2 infused over 1 hour, and 24 hours later light doses escalating
from 100 J/cm2 to 125 and 140 J/cm2, respectively. The primary goal is the determination of
the maximally tolerated PDT dose. Preliminary evidence for PDT efficacy wil also be
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximally tolerated dose in the oral cavity and/or oropharynx of photodynamic therapy (PDT) using HPPH (2-1 (hexyloxyethyl)-2- devinylpyropheophorbide-a) and 665 nm light.
Nestor Rigual, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|