Phase I study of subcutaneously administered interleukin-2 in combination with interferon alfa-2a in patients with advanced cancer

B. L. Gause, M. Sznol, W. C. Kopp, J. E. Janik, II W. Smith, R. G. Steis, W. J. Urba, W. Sharfman, R. G. Fenton, S. P. Creekmore, J. Holmlund, K. C. Conlon, L. A. VanderMolen, D. L. Longo

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30 Scopus citations


Purpose: Although high-dose interleukin-2 (IL-2) can produce durable remissions in a subset of responding patients with renal cell carcinoma (RCC), this occurs in the setting of significant toxicity. The purpose of this study is to define the maximum-tolerated dosage (MTD) of IL-2 and interferon alfa-2a (IFNα-2a) that can be administered chronically on an outpatient basis. Patients and Methods: Fifty-three patients with advanced cancer of variable histology with good prognostic features were treated in six cohorts. Patients in cohorts one through five received IL-2 (1.5 or 3.0 x 106 million units (mU)/m2) Monday through Friday and IFNα-2a (1.5 or 3 x 106 mU/m2) daily for a 4-week cycle. In cohort six, IFNα-2a was given three times a week. Immunologic monitoring, including serum levels of soluble IL-2 receptor (sIL-2R) and neopterin, flow cytometry, and natural killer cell (NK) activity, were measured. Patients were evaluated for toxicity, response, and survival. Results: Almost all patients developed grade I/II toxicities commonly associated with cytokine therapy. Symptoms were most severe with the first treatment of each week. Dose-limiting toxicities included grade III fatigue, hypotension, and creatinine elevations. The MTD was 1.5 mU/m2 daily x 5 given subcutaneously repeated weekly for IL-2 and 1.5 mU/m2 daily subcutaneously (dose level 3) for IFN. Six of 25 assessable patients with RCC (24%) achieved a partial response (PR), including four of eight patients who were previously untreated. There were no objective responses in patients with other tumors, including 12 melanoma patients. Conclusion: IL-2 and IFNα-2a can be given with tolerable toxicities on an outpatient basis and shows significant activity in patients with metastatic RCC.

Original languageEnglish (US)
Pages (from-to)2234-2241
Number of pages8
JournalJournal of Clinical Oncology
Issue number8
StatePublished - Jan 1 1996
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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