Non-melanomatous Skin Cancer Clinical Trial
Official title:
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)
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive
to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer
cells and, when exposed to light, become active and kill the cancer cells.
PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in
treating patients who have basal cell skin cancer.
OBJECTIVES:
- Determine the safety of HPPH used in photodynamic therapy in patients with basal cell
skin cancer.
- 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
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