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
Condition: Lymphoma; Non-melanomatous Skin Cancer; Precancerous Condition
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides; Skin Neoplasms; Precancerous Conditions; Disease
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): silicon phthalocyanine 4
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Pc 4
Intervention MeSH terms: Silicon; Silicon phthalocyanine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin cancer; squamous cell carcinoma of the skin; basal cell carcinoma of the skin; recurrent skin cancer; recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; actinic keratosis; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma