Vaccine Therapy in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Detailed Description
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OBJECTIVES: Primary Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail. Secondary Determine immunologic response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2. Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically until disease progression. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Official Title
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A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: MART-1 antigen
* Biological: gp100:209-217(210M) peptide vaccine
* Biological: therapeutic autologous dendritic cells
* Biological: tyrosinase peptide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of melanoma Metastatic disease The following melanoma subtypes are eligible: Unresectable, stage III-IV uveal melanoma Metastatic mucosal melanoma Measurable disease after attempted curative surgical therapy Tumor tissue must be available for immunohistochemical staining Positive for ≥ 1 of the following peptides: MART-1: 26-35 (27L) gp100: 209-217 (210M) Tyrosinase: 368-376 (370D) HLA-A *0201 positive by DNA polymerase chain reaction assay PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% Creatinine ≤ 2.0 mg/dL Bilirubin ≤ 2.0 mg/dL WBC ≥ 3,000/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 9.0 g/dL No major systemic infections No coagulation disorders No major medical illness of the cardiovascular or respiratory system No myocardial infarction within the past 6 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No know positivity for hepatitis B surface antigen or hepatitis C antibody No prior uveitis or autoimmune inflammatory eye disease No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than 1 prior cytotoxic chemotherapy agent or regimen Prior biologic or antiangiogenic therapies allowed More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides No concurrent steroid therapy

Ages Eligible for Study
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Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Biological: MART-1 antigen|nan|
|Biological: gp100:209-217(210M) peptide vaccine|nan|
|Biological: therapeutic autologous dendritic cells|nan|
|Biological: tyrosinase peptide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Time to progression |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension melanoma