A Phase I Study Of Photodynamic Therapy (PDT) For The Treatment Of Basal Cell Carcinoma (BCC): A Drug/Light Dose Finding Study Utilizing 2-(1-HEXYLOXYETHYL)-2-DEVINYL PYROPHEOPHORBIDE-A (HPPH-PHOTOCLOR)
- Determine the safety of HPPH used in photodynamic therapy in patients with basal cell
- Determine the drug dose, light dose, and treatment interval combinations that do not
produce excessive toxicity to normal skin but effect tumor response in these patients
treated with this regimen.
- Determine the length of time for cutaneous photosensitivity in these patients treated
with this regimen.
- Determine the plasma clearance rates for HPPH in these patients.
- Determine the best combination of treatment parameters for a phase II study.
OUTLINE: This is a dose-escalation study.
Patients receive HPPH IV on day 1. Patients undergo phototherapy on days 2-3.
Cohorts of 2-6 patients receive escalating doses of HPPH and phototherapy to determine the
minimum erythemal dose (MED). The MED is defined as the dose combination of HPPH and laser
light preceding that at which at least 1 patient experiences grade 3 or worse toxicity or at
which at least 2 patients experience grade 1 or worse toxicity.
Patients are followed daily for 4 days, at week 1, and at months 1, 3, 6, 12, and 24.
PROJECTED ACCRUAL: A total of 4-25 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Allan R. Oseroff, MD, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|