Status:
COMPLETED
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
Lead Sponsor:
University of Oklahoma
Conditions:
Melanoma (Skin)
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00453050
Start Date
March 1 2006
Last Update
May 6 2015
Active Locations (1)
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1
Oklahoma University Cancer Institute
Tulsa, Oklahoma, United States, 74135-2512