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

Phase 2CompletedNCT00032045

National Cancer Institute (NCI)

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Intraocular Melanoma Melanoma (Skin)

Interventions

gp100 antigenBIOLOGICAL

incomplete Freund's adjuvantBIOLOGICAL

ipilimumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.