Status:
COMPLETED
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
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 phtha...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00103246
Start Date
September 1 2004
End Date
August 1 2010
Last Update
January 22 2019
Active Locations (1)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065