TREATMENT OF RENAL-CELL CARCINOMA WITH ALPHA-(HUMAN LEUKOCYTE) INTERFERON AND VINBLASTINE IN COMBINATION - A PHASE I-II TRIAL

Abstract

Twenty-four patients with measurable metastatic renal cell carcinoma were treated in a phase I-II trial with .alpha.(human leukocyte) interferon (.alpha.IFN) and vinblastine (VBL) in combination. Patients received 3 .times. 106 IU/day of .alpha.IFN i.m. 5 days/wk and VBL i.v. weekly (at a starting dose of 0.15 mg/kg), with doses modified for toxicity. All patients were evaluable for toxicity; 23 patients were evaluable for response. An objective response rate of 13% was observed (3 partial responses). An additional 22% of patients had minimal responses (5 patients). The occurrence of nausea, vomiting, thrombocytopenia, hepatic dysfunction and fever was comparable to that seen in previous studies of .alpha.IFN alone. Granulocytopenia, neurotoxicity and malaise, however, occurred with increased frequency and severity. .alpha.IFN and VBL administered in combination in this dose schedule demonstrated activity similar to but toxicity greater than that seen in previous trials of .alpha.IFN alone.