Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
Intraocular Melanoma, Melanoma (Skin)
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma Resected or rendered disease-free HLA-A2.1-positive by standard cytotoxicity assay Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry Must be positive for at least 1 antigen Failed, ineligible for, or refused prior interferon alfa PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times normal No coagulation disorder Hepatitis surface antigen B negative Hepatitis C negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness Immunologic: No prior uveitis No prior autoimmune inflammatory eye disease No immune hemolytic anemia No other active autoimmune disease Other: HIV negative No major gastrointestinal illness No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago No major systemic infection (e.g., pneumonia or sepsis) No other major medical illness No prior allergic reaction to Montanide ISA-51 or alum adjuvant No requirement for steroid therapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides Chemotherapy: At least 1 month since prior adjuvant chemotherapy for this disease No concurrent adjuvant chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: At least 1 month since prior radiotherapy for this disease No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 1 month since other prior therapy, including adjuvant therapy, for this disease No other concurrent therapy, including adjuvant therapy
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital