Novel Adjuvants for Peptide-Based Melanoma Vaccines

Study Overview
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Brief Summary
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This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.

Detailed Description
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In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

Official Title
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An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma Completely resected disease or disease-free HLA-A2.1 positive Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy WBC count at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 gm/dL Creatinine no greater than 2.0 mg/dL Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal ECOG performance status 0-1 Have failed alpha-interferons (patients with resected stage III disease) Exclusion criteria: Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides Steroid therapy or other immunosuppressive medication requirement Major systemic infections (e.g., pneumonia or sepsis) Coagulation or bleeding disorders Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) History of uveitis or autoimmune inflammatory eye disease Other active autoimmune disease Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody Pregnant or nursing

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

| Intervention/Treatment |
| --- |
|Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine|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, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol, Adjuvants, Immunologic, Melan-A Protein, Antigens, Neoplasm, Antibodies, Melanocyte lineage-specific antigen gp100, CTLA-4