Melanoma (Skin)
Conditions
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.
Detailed description
OBJECTIVES: * Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma. * Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens. * Compare tumor response in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6. * Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days. Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.
Interventions
BIOLOGICALMAGE-10.A2
BIOLOGICALMART-1 antigen
BIOLOGICALNY-ESO-1 peptide vaccine
BIOLOGICALsargramostim
BIOLOGICALtyrosinase peptide
Sponsors
National Cancer Institute (NCI)
Herbert Irving Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed high-risk stage III or IV melanoma * Stage III disease less than 6 months after surgical resection * Completed prior interferon alfa therapy OR * Progressive disease or major adverse events during prior interferon alfa therapy * Stage III disease at least 6 months after surgical resection * Declined, failed, or completed prior standard therapy * Stage IV disease * Declined, failed, or completed prior standard therapy * HLA-A2 positive * No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 80-100% Life expectancy: * At least 4 months Hematopoietic: * Neutrophil count at least 1,500/mm3 * Lymphocyte count at least 500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) * No bleeding disorder Hepatic: * Bilirubin no greater than 2.0 mg/dL * No hepatitis B or C positivity Renal: * Creatinine no greater than 1.8 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * HIV negative * No other serious illness * No serious infection requiring antibiotics * No history of immunodeficiency disease or autoimmune disease * No psychiatric or addictive disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior bone marrow or stem cell transplantation * At least 4 weeks since prior immunotherapy or biologic therapy * No other concurrent immunotherapy or biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No concurrent chemotherapy Endocrine therapy: * No concurrent systemic corticosteroids * No concurrent steroids except topical or inhalational steroids * Concurrent hormonal therapy allowed Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery Other: * At least 4 weeks since prior investigational agents * Concurrent noncytotoxic anticancer therapy allowed * No concurrent immunosuppressive therapy * No concurrent antihistamines * No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control
Countries
United States
Outcome results
None listed