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A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. Photodynamic therapy using methyl-5-aminolevulinate hydrochloride cream may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy with methyl-5-aminolevulinate hydrochloride cream in determining pain threshold patients with skin cancer
Details
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2011-03 |
| Completion | 2014-09 |
Conditions
- Basal Cell Carcinoma of the Skin
- Pain
- Recurrent Skin Cancer
Interventions
- methyl-5-aminolevulinate hydrochloride cream
- photodynamic therapy
- laser therapy
Primary outcomes
- Irradiance-dependent pain threshold — 30-60 sec after the initial "low" irradiance treatment, every 3-5 min until irradiance increase, 30-60 sec after the "high" irradiance increase, and every 3-5 min until end of treatment
Countries
United States