Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
This trial is active, not recruiting.
|Treatments||mage-10.a2, mart-1 antigen, ny-eso-1 peptide vaccine, sargramostim, tyrosinase peptide|
|Sponsor||Herbert Irving Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2001|
|Trial identifier||NCT00037037, CDR0000069357, CPMC-IRB-13824, LUDWIG-LUD00-025, NCI-G02-2068|
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.
Male or female participants at least 18 years old.
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
|Official title||A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma|
|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.|
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