Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and Stage I Carcinoma of the Oral Cavity
- To determine the maximum tolerated dose in the oral cavity of photodynamic therapy
(PDT) using HPPH and 665 nm light in patients with recurrent dysplasia, carcinoma in
situ, or stage I squamous cell carcinoma of the oral cavity.
- To determine response of dysplasia, carcinoma in situ, and selected patients with T1
squamous cell carcinoma of the oral cavity using PDT with HPPH and 665 nm light.
OUTLINE: This is a dose-escalation study of laser light dose therapy.
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours after receiving HPPH,
patients undergo laser light treatment to the tumor bed on day 2. Patients with multicentric
or large area confluent disease receive a second course of treatment at least 8 weeks later
for lesions untreated at the first treatment session.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nestor R. Rigual, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|