Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.

Detailed Description
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OBJECTIVES: Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51. Determine a safety and adverse event profile of this regimen in these patients. Determine improved immunologic response in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.

Official Title
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An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma

Conditions
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Intraocular Melanoma, Melanoma (Skin)

Intervention / Treatment
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* Biological: gp100 antigen
* Biological: incomplete Freund's adjuvant
* Biological: ipilimumab


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Mucosal or ocular melanoma allowed Clinically evaluable disease HLA-A*0201 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 2,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hematocrit at least 30% Hepatic: AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 2.0 mg/dL Immunologic: Antinuclear antibody negative Thyroglobulin antibody normal Rheumatoid factor normal HIV negative No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active infection No hypersensitivity to Montanide ISA-51 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix No other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy for melanoma and recovered No prior gp100 peptides No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: At least 3 weeks since prior chemotherapy for melanoma and recovered No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy for melanoma and recovered At least 4 weeks since prior systemic or topical corticosteroids No concurrent topical or systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: Not specified Other: No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: gp100 antigen|nan|
|Biological: incomplete Freund's adjuvant|nan|
|Biological: ipilimumab|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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iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage IV melanoma, recurrent melanoma