Intraocular Melanoma, Melanoma (Skin)
Conditions
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma, recurrent intraocular melanoma, iris melanoma, extraocular extension melanoma, ciliary body and choroid melanoma, medium/large size
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
Detailed description
OBJECTIVES: * Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51. OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Unresectable stage III or IV disease * Mucosal or ocular disease allowed * Positive HLA-A1, -A2, or -A3 expression PATIENT CHARACTERISTICS: Age * 12 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL Hepatic * Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Weight ≥ 100 pounds * Not pregnant or nursing * No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior vaccination with any of the peptides used in this protocol * More than 1 year since prior melanoma vaccine therapy * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior growth factors * More than 4 weeks since prior allergy shots Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior steroid therapy Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Prior tumor resection allowed
Countries
United States