Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.

Detailed Description
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OBJECTIVES: Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic cells pulsed with tumor antigen peptides in patients with stage III melanoma following lymphadenectomy. Determine the immune response (skin test of delayed-type hypersensitivity and flow cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this regimen in these patients. Determine clinical outcome (disease-free survival, overall survival, and adverse events) in patients treated with this regimen. OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients with no evidence of disease may receive another booster injection 5 years after the start of vaccination. Blood samples are examined via flow cytometry and skin testing is performed to evaluate immune response.

Official Title
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Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine
* Biological: HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine
* Biological: autologous melanoma lysate-pulsed autologous dendritic cell vaccine
* Biological: autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine
* Biological: dendritic cell-idiotype-keyhole limpet hemocyanin vaccine
* Other: flow cytometry
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage III melanoma Has undergone therapeutic lymphadenectomy More than 1 lymph node involvement or extracapsular extension of metastatic melanoma cells (stage N1b-N3 disease according to AJCC 2002) HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available) No presence of distant metastases PATIENT CHARACTERISTICS: No other malignancy No evidence of lung, heart, liver, or renal failure or severe neurologic disorder No autoimmune disease or atopic allergy No HIV infection or presence of anti-HIV antibodies No presence of hepatitis B surface antigen or antibodies against hepatitis C virus PRIOR CONCURRENT THERAPY: See Disease Characteristics

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 |
| --- |
|Biological: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine|nan|
|Biological: HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine|nan|
|Biological: autologous melanoma lysate-pulsed autologous dendritic cell vaccine|nan|
|Biological: autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine|nan|
|Biological: dendritic cell-idiotype-keyhole limpet hemocyanin vaccine|nan|
|Other: flow cytometry|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response |  |  | 
| Disease-free survival |  |  | 
| Overall survival |  |  | 
| Adverse events |  |  | 

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