Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Study Overview
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Brief Summary
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51. OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Official Title
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Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: incomplete Freund's adjuvant
* Biological: multi-epitope melanoma peptide vaccine
* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of melanoma Unresectable stage III or IV disease Mucosal or ocular disease allowed Positive HLA-A1, -A2, or -A3 expression PATIENT CHARACTERISTICS: Age 12 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 9 g/dL Hepatic Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Other Weight ≥ 100 pounds Not pregnant or nursing No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccination with any of the peptides used in this protocol More than 1 year since prior melanoma vaccine therapy More than 4 weeks since prior immunotherapy More than 4 weeks since prior growth factors More than 4 weeks since prior allergy shots Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior steroid therapy Radiotherapy More than 4 weeks since prior radiotherapy Surgery Prior tumor resection allowed

Ages Eligible for Study
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Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: incomplete Freund's adjuvant|nan|
|Biological: multi-epitope melanoma peptide vaccine|nan|
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 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, recurrent melanoma, recurrent intraocular melanoma, iris melanoma, extraocular extension melanoma, ciliary body and choroid melanoma, medium/large size