Phase I Trial of Interleukin-12 Followed by Interferon-Alpha

Date de début de l'étude : 1 août 1998

DISEASE CHARACTERISTICS: Histologically confirmed residual, recurrent, or metastatic malignant melanoma or other advanced malignancies Must have failed standard curative and/or palliative therapies No brain or central nervous system metastases PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (may be posttransfusion or may receive erythropoietin) Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Calcium no greater than 11 mg/dL (may receive agents to decrease calcium) No significant cardiovascular disease No cardiac arrhythmia requiring drug or device intervention No history of significant peripheral neuropathy No significant central nervous system disease HIV negative Hepatitis B surface antigen negative No concurrent serious infection requiring intravenous antibiotic therapy No clinically significant autoimmune disease (i.e., rheumatoid arthritis) No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease No history of inflammatory bowel disease No other major illness that substantially increases the risk associated with participation in this study Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: At least 4 weeks since prior biologic therapy At least 4 weeks since prior chemotherapy No concurrent systemic corticosteroids At least 2 weeks since prior local radiotherapy At least 2 weeks since surgery Other: At least 4 weeks since prior investigational drug