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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 and cutaneous metastases. Determine the complete systemic and local response rates in patients treated with this regimen. Secondary Determine the effect of this treatment on immunologic parameters in these patients. OUTLINE: This is a prospective, open-label, pilot study. Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and 28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by flow cytometry), and antibody response (by western blot). After completion of study treatment, patients are followed monthly for 3 months and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Official Title
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Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

Conditions
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Melanoma (Skin), Metastatic Cancer

Intervention / Treatment
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* Drug: imiquimod
* Drug: indocyanine green solution
* Other: flow cytometry
* Other: immunologic technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imiquimod|nan|
|Drug: indocyanine green solution|nan|
|Other: flow cytometry|nan|
|Other: immunologic technique|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity and tolerability by CTCAE version 3.0 |  |  | 
| Complete systemic and local response rates at 16 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunologic parameters |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III melanoma, stage IV melanoma, skin metastases