Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have basal cell skin cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-morpheaform basal cell skin cancer

• Primary disease OR

• Recurrent disease after prior therapy (e.g., surgical excision, electrodesiccation, cryosurgery, or radiotherapy)

• At least 4 lesions, no greater than 2 cm in diameter and no greater than 5 mm in depth

• No lesions located on the eyelid, nose, ear, periauricular area, genitals, or digits, or any other lesions thought to be deep and/or aggressive

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 120,000/mm^3

Hepatic:

• PT/PTT no greater than 1.5 times upper limit of normal (ULN)

• Bilirubin no greater than 3.0 mg/dL

• Liver enzymes no greater than 2 times ULN

• No impaired hepatic function

Renal:

• No impaired renal function

Cardiovascular:

• No myocardial infarction within the past 6 months

Other:

• No porphyria

• No known hypersensitivity to porphyrins

• No systemic lupus erythematosus

• No history of positive antinuclear antibody

• No history of degenerative disease of the retina

• No xeroderma pigmentosum

• No pancreatic disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 months since prior combination doxorubicin and radiotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• See Chemotherapy

Surgery:

• See Disease Characteristics