Expired Study
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Cleveland, Ohio 44106


Purpose:

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 patients with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in patients 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 patients. - Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these patients. - Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these patients. OUTLINE: This is a dose-escalation study. Patients receive topical silicon phthalocyanine 4 (Pc 4). One hour later, patients 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 patients 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 patients experiences dose-limiting toxicity. Three additional patients are treated at the MTD. After completion of study therapy, patients are followed for up to 2 weeks. PROJECTED ACCRUAL: A total of 16-45 patients will be accrued for this study.


Criteria:

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


NCT ID:

NCT00103246


Primary Contact:

Principal Investigator
Kevin Cooper, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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