Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma

Date de début de l'étude : 1 mars 2000

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell carcinoma or malignant melanoma Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor Bidimensionally measurable of evaluable disease No significant effusions and/or ascites No more than 3 prior regimens for metastatic disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 3 months 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 1.5 mg/dL ALT/AST no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.8 mg/dL Calcium no greater than 11.5 mg/dL Cardiovascular: No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment No congestive heart failure No angina pectoris No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active peptic ulcer No autoimmune disease No inflammatory bowel disease No local or systemic infections requiring IV antibiotics within the past 28 days No known seizure disorder No other prior malignancy except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any curatively treated malignancy in complete remission for at least 3 years HIV, hepatitis B surface antigen, and hepatitis C negative PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior biologic therapy Chemotherapy: Recovered from prior chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy and recovered No concurrent corticosteroids except for replacement steroids Radiotherapy: Recovered from prior radiotherapy At least 28 days since prior radiotherapy for control of pain from skeletal lesions Surgery: At least 28 days since prior major surgery requiring general anesthesia No organ allografts Other: No concurrent aspirin No concurrent barbiturates No other concurrent investigational agents