Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage IV melanoma Measurable disease At least 1 lesion must be a minimum of 1.0 cm in diameter Bone metastases are not considered to be measurable disease No prior radiotherapy to area of measurable disease unless there is clearly progressive disease in this site or measurable disease exists outside the area of prior radiotherapy HLA-A2 positive No brain disease by MRI or CT scan within 4 weeks prior to randomization Prior brain disease allowed if no evidence of active disease by 2 successive MRI evaluations completed at least 3 months apart PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Lymphocyte count greater than 700/mm ^3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Alkaline phosphatase and lactic dehydrogenase no greater than 2 times ULN Renal: Creatinine no greater than 1.8 mg/dL Other: No significant detectable infection HIV negative No other malignancy within the past 5 years except: Any carcinoma in situ Lobular carcinoma in situ of the breast Carcinoma in situ of the cervix Atypical melanocytic hyperplasia Melanoma in situ Basal cell or squamous cell skin cancer No autoimmune disorders or conditions of immunosuppression Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior MART-1:27-35, gp100:209-217 (210M), or tyrosinase:368-376 (370D) peptide Greater than 4 weeks since prior adjuvant immunotherapy, including sargramostim (GM-CSF) or interferon alfa-2b Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: At least 2 weeks since prior and no concurrent systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone); continuous use of topical steroid creams or ointments; or any inhalers containing steroids Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy for local control or palliation and recovered Surgery: Recovered from any prior major surgery
Sites / Locations
- CCOP - Scottsdale Oncology Program
- Emory University Hospital - Atlanta
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Veterans Affairs Medical Center - Lakeside Chicago
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- CCOP - Evanston
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Iowa Oncology Research Association
- CCOP - Wichita
- CCOP - Ochsner
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tuft-New England Medical Center
- Beth Israel Deaconess Medical Center
- CCOP - Kalamazoo
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey
- Albert Einstein Clinical Cancer Center
- Ireland Cancer Center
- CCOP - Toledo Community Hospital
- CCOP - Geisinger Clinic and Medical Center
- University of Pennsylvania Cancer Center
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute
- CCOP - Sioux Community Cancer Consortium
- CCOP - Scott and White Hospital
- Cancer Center at the University of Virginia
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- Veterans Affairs Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation