Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.

Detailed Description
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OBJECTIVES: Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma. Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients. OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod. Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1. A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine. Step 2: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod on day 1. Cohorts of 3-6 patients receive escalating doses of resiquimod until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Step 3: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod at the step 2 dose as in step 2. Cohorts of 3-6 patients receive resiquimod to increasing amounts of surface area until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. Blood is drawn at baseline and periodically during study treatment and observation. Samples are analyzed by flow cytometry, monoclonal antibody staining, ELISPOT, and ELISA. After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Official Title
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Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: resiquimod


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Prior diagnosis of melanoma meeting the following criteria: Stage II-IV disease Complete resection of disease No current evidence of disease HLA-A2 positive No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 75,000/mm³ AST ≤ 3 times upper limit of normal No uncontrolled or current infection No known allergy to vaccine or adjuvant components Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known immune deficiency PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 4 weeks since prior chemotherapy and recovered More than 4 weeks since prior biologic therapy No concurrent immunosuppressive therapy

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunization with NY-ESO-1b<br>Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine. | Drug: resiquimod<br>* Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of hematologic and non-hematologic toxicities |  | 4 weeks | 
| Toxicity profile of each dose level |  | 4 weeks | 
| Percent of patients who mount an immune response |  | 4 weeks | 

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