Overview
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
Status:
Completed
Completed
Trial end date:
2010-08-01
2010-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Case Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Silicon
Silicon phthalocyanine
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