Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.

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

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Imiquimod

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma meeting the following criteria:

• Stage III or IV disease

• Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed

• Presence of 1 or more cutaneous metastases ≤ 3 cm in size

• Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness

• No uncontrolled brain metastases

• Treated brain metastases that are stable for 3 months allowed at the investigator's discretion

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 4 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 month after study completion

• No known allergy to any drugs used during study treatment

• No unstable medical illness

• Not immunosuppressed

• Patients immunosuppressed due to disease (e.g., HIV positive) allowed

PRIOR CONCURRENT THERAPY:

• No systemic steroids or any other immunosuppressive medications within the past month

• No chemotherapy within the past 4 weeks

• No radiotherapy to the treatment site within the past 4 weeks

• Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed

• No concurrent immunosuppressive agents