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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma, Non-melanomatous Skin Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: silicon phthalocyanine 4


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Actinic keratosis Bowen's disease Squamous cell skin cancer Basal cell skin cancer Clinical stage IA, IB, IIA, or IIB mycosis fungoides Fitzpatrick skin type I-IV PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patient must use effective contraception No diabetes mellitus No known hypersensitivity to ethanol or propylene glycol No significant history of photosensitivity, including diagnosis of any of the following: Porphyria Lupus erythematosus Xeroderma pigmentosum Severe polymorphous light eruption Solar urticaria PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 2 weeks since prior anticancer radiotherapy No concurrent radiotherapy Surgery Lesions must be healed after prior biopsy Other More than 2 weeks since prior topical, local, or systemic anticancer therapy More than 2 weeks since prior anticancer phototherapy More than 2 weeks since prior photosensitizing medications, including any of the following: Tetracyclines Quinolones Psoralens Hydrochlorothiazide Furosemide Trimethoprim-sulfamethoxazole Griseofulvin Nalidixic acid Amiodarone Phenothiazines High-dose nonsteroidal anti-inflammatory drugs No other concurrent photosensitizing medications No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy<br>Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy. | Drug: silicon phthalocyanine 4<br>* 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.<br>* Other names: Pc 4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | Treatment repeats weekly for up to 3 weeks. Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. | 
| Local toxicity as measured by physical exam and punch biopsy |  | at 24 hours and 2 weeks after the start of study treatment | 
| Treatment efficacy as measured by physical exam and punch biopsy |  | at 24 hours and 2 weeks after the start of study treatment | 
| Systemic photosensitivity as measured by minimum erythema dose (MED) testing |  | at 2, 24, and 48 hours after completion of photodynamic therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage II mycosis fungoides/Sezary syndrome, actinic keratosis