Phase I/II trial of outpatient PEG-interferon with interleukin-2 in advanced renal cell carcinoma: A cytokine working group study

Joseph I. Clark*, Jessica Mehrabi, Jeffrey A. Sosman, Theodore F. Logan, Kim A. Margolin, Janice P. Dutcher, Walter J. Urba, Marc S. Ernstoff, David F. McDermott, Ann M. Lau, Michael B. Atkins

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


A phase I/II trial was undertaken to determine the maximum tolerated dose of polyethylene glycol interferon-α-2b (PEG-IFN) with interleukin-2 (IL-2), and to evaluate the efficacy and toxicity in patients with metastatic renal cell carcinoma. Patients initially received subcutaneous PEG-IFN, 3.0 mcg/kg/wk, combined with IL-2, but owing to unexpected toxicity a revised phase I schedule ensued. Patients received 1.0, 1.5, 2.0, or 3.0 mcg/kg/wk of PEG-IFN on days 1, 8, 15, and 22; subcutaneous IL-2 was given at a dose of 5×10 IU/m every 8 hours×3 on day 1, followed daily at 5×10 IU/m days 2, 3, 4, and 5 of week 1, then 5 times per week for 3 weeks, followed by 2 weeks off. The maximum tolerated dose of PEG-IFN was 2.0 mcg/kg/wk. Fifty-four patients were enrolled. Frequent grade III/IV cardiac and neurologic toxicities led to an expanded phase I trial. Eleven serious events in 33 patients in the phase II portion led to early termination. No patient died from treatment. The overall response rate in 53 evaluable patients was 30.2% (95% confidence interval 20.5-39.9), with 2 complete responses and 14 partial responses and at least 1 response at each dose level. The median duration of response was 11 months (range, 2 to 65+ mo); median survival was 20 months (range, 2 to 71+ mo); median time to progression was 4 months. Despite clinical efficacy, the study was closed prematurely owing to excess toxicity. Although all serious adverse events resolved, this degree of toxicity is unacceptable for an outpatient treatment regimen.

Original languageEnglish (US)
Pages (from-to)839-846
Number of pages8
JournalJournal of Immunotherapy
Issue number8
StatePublished - Nov 2007


  • CWG
  • Interleukin-2
  • PEG-interferon
  • Phase I/II
  • Renal cell carcinoma

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology
  • Cancer Research


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