Clinical studies with biological response modifiers in the treatment of solid tumors

Summary Purpose: A single-institution phase II study was undertaken to evaluate the efficacy andtoxicity of interleukin-2 (IL-2) administration by subcutaneous injection.Patients and Methods: Twenty-seven unselected patients (15 male) with a mean age of 60years (range, 42 to 76 years) who had advanced renal cell cancer were treated as outpatients.IL-2 was given once a day, 5 days per week for 6 weeks. During the first 5-day cycle, 18 x10 6 IU was given once daily; in the following cycles, the doses in the first 2 days werereduced to 9 x 10 6 IU. After a 3-week rest period, treatment was repeated in patients who hada response or stable disease (SD). To prevent pyretic reactions, patients also receivedacetaminophen (250 to 500 mg given orally every 4 to 6 hours).Results: After 6 weeks, 26 patients were assessable for response. Two patients (8%) had acomplete remission (CR), four (15%) had a partial remission (PR), and 13 (50%) had SD.A second cycle was given to 19 patients; one patient with a PR and six with SD showedprogression. Duration of CR the was 17+ and 19+ months, and length of the PR was 2, 8,11, and 11+ months. The median survival of the patients who were nonresponders andresponders was 10 and 20+ months, respectively, and for all patients was 13 months. Onepatient died as a result of myocardial infarction and brain stem ischemia. Systemic sideeffects in other patients were tolerated and accepted, and included transient inflammation andlocal induration at the injection sites, fever and chills, and nausea.Conclusion: Subcutaneous IL-2 is clinically active, has an acceptable toxicity, and can begiven to patients with concomitant disease.51