Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma

Date de début de l'étude : 1 août 1998

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