Combination Chemotherapy Plus 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 III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma Stage III with intransit metastases Stage IV No uncontrolled brain metastases by CT scan No clinically significant ascites or pleural effusions PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 10 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.5 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 70 mL/min Cardiovascular: No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan Pulmonary: No clinically significant pulmonary disease on chest x-ray Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant thyroid dysfunction No concurrent severe infection No other medical or psychiatric condition that would interfere with compliance No second malignancy within the past 5 years, except: Localized nonmelanomatous skin cancer Carcinoma in situ of the cervix Grade 1 Ta bladder cancer Suspected hearing deficits must undergo audiologic testing PRIOR CONCURRENT THERAPY: Biologic therapy: No more than one prior immunotherapy regimen At least 4 weeks since prior immunotherapy Adjuvant interferon alfa before relapse allowed Chemotherapy: No more than one prior chemotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) No concurrent cyclophosphamide No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids or cyclosporine A Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 3 weeks since major surgery Other: No concurrent immunosuppressive drugs No other concurrent investigational antineoplastic drugs Concurrent thyroid replacement therapy allowed
Sites / Locations
- University of Chicago Cancer Research Center
Arms of the Study
Arm 1
Experimental
Arm A
CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14.