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
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
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