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.

Condition	Treatment or Intervention	Phase
actinic keratosis Cutaneous T-Cell Lymphoma Skin Cancer	Drug: silicon phthalocyanine 4  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: laser therapy  Procedure: photodynamic therapy  Procedure: phototherapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting

Study chairs or principal investigators

Kevin Cooper, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000410675; CWRU-CASE-1Y04; CWRU-100301; NCT00103246
Record last reviewed:  January 2005
Last Updated:  February 15, 2005
Record first received:  February 7, 2005
ClinicalTrials.gov Identifier:  NCT00103246
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08