Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides

Lymphoma Clinical Trial

Official title: Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions

Status Completed

Clinical Trial Summary

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.

Clinical Trial Description

OBJECTIVES:

• Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis, Bowen's disease, squamous cell or basal cell skin cancer, or stage IA, IB, IIA, or IIB mycosis fungoides.

• Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants .

• Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants.

• Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants.

OUTLINE: This is a dose-escalation study.

Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).

Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD.

After completion of study therapy, participants are followed for up to 2 weeks.

PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study. ;

Related Conditions & MeSH terms

• Disease
• Keratosis, Actinic
• Lymphoma
• Mycoses
• Mycosis Fungoides
• Non-melanomatous Skin Cancer
• Precancerous Condition
• Precancerous Conditions
• Skin Neoplasms

• NCT number: NCT00103246
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: September 2004
• Completion date: August 2010