Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx
- To determine the maximum tolerated dose of laser light therapy using a fixed dose of
HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell
carcinoma of the larynx.
- To determine response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of laser light therapy.
Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser
light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial
response, no response, or a geographical miss may receive a second course of treatment.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
then periodically thereafter.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Nestor R. Rigual, MD
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|