Expired Study
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Tampa, Florida 33612


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma. PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.


Study summary:

OBJECTIVES: Primary - Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51. Secondary - Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen. - Determine the time to disease relapse in patients treated with this regimen. - Determine the 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 (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Stage III (≥ 3 positive lymph nodes) or stage IV disease - Mucosal or ocular melanoma allowed - Completely resected within the past 6 months - Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa - Positive staining of tumor tissue for at least one of the following: - Antibody HMB-45 for gp100 - Antibody HMB-45 for tyrosinase - Antibody HMB-45 for MART-1 - HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 6 months Hematopoietic - WBC ≥ 2,500/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hematocrit ≥ 30% - Hemoglobin ≥ 10 g/dL Hepatic - AST ≤ 3 times upper limit of normal (ULN)* - Bilirubin ≤ ULN* (< 3.0 mg/dL for patients with Gilbert's syndrome) - No significant hepatic disease that would preclude study participation - Hepatitis B surface antigen negative - Hepatitis C antibody negative NOTE: * Unless attributable to disease Renal - Creatinine ≤ 2.0 mg/dL - No significant renal disease that would preclude study participation Cardiovascular - No significant cardiac disease that would preclude study participation Pulmonary - No significant pulmonary disease that would preclude study participation Immunologic - No history of any of the following: - Inflammatory bowel disease or any other autoimmune bowel disease - Systemic lupus erythematosus - Rheumatoid arthritis - Autoimmune ocular disease - No systemic hypersensitivity to Montanide ISA-51 or any vaccine component - No active infection requiring therapy - HIV negative Other - 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 significant gastrointestinal disease that would preclude study participation - No significant psychiatric disease that would preclude study participation - No other medical condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) - No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide - At least 4 weeks since prior immunotherapy for melanoma and recovered - No other concurrent immunotherapy Chemotherapy - At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy - At least 4 weeks since prior hormonal therapy for melanoma and recovered - At least 4 weeks since prior systemic, inhaled, or topical corticosteroids - No concurrent systemic, inhaled, or topical corticosteroids Radiotherapy - At least 4 weeks since prior radiotherapy for melanoma and recovered Surgery - See Disease Characteristics - At least 4 weeks since prior surgery for melanoma and recovered Other - No concurrent immunosuppressive agents (e.g., cyclosporine and its analog) - Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days


NCT ID:

NCT00084656


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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