Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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)


NCT ID:

NCT00032045


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
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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