A Phase II Trial of Temozolomide and IFN-α in Patients with Advanced Renal Cell Carcinoma

Usha Sunkara, Janet R. Walczak, Lori Summerson, Theresa Rogers, Mario Eisenberger, Samuel R Denmeade, Roberto Pili, Carol Ann Huff, Victoria Sinibaldi, Michael A Carducci

Research output: Contribution to journalArticle


The combination of temozolomide (TEM) and interferon-α (IFN-α) previously demonstrated a 30% response rate in metastatic melanoma. A single institution, phase II trial evaluating the efficacy of TEM/IFN in patients with advanced renal cell carcinoma (RCC) was conducted. Safety and tumor response were the main outcomes. Eligible patients received 200 mg/m2/day TEM orally on days 1-5 every 28 days, with IFN 2.5 million U/m2/day subcutaneously (s.c.) three alternate days/week for days 1-15 first cycle, then 5 million U/m2/day s.c. 3 alternate days/week throughout each 28-day cycle. Efficacy was evaluated every 8 weeks, and dose-limiting toxicities (DLTs) were treated with dose reductions of the culprit drug. Sixteen patients (ages 37-67) were initially enrolled. Of the 14 evaluable patients, there was one minor response. Best response was stable disease, with 7 patients remaining on study for ≥6 months. Five were alive for more than 2 years, and 2 remain alive at 45 and 50 months after enrollment. DLTs included TEM-induced myelosuppression and IFN-induced fever/chills. Other toxicities were mild to moderate (grades 1-3). The combination of TEM/IFN proved quite tolerable. This regimen appears inactive in terms of response in this population with poor prognosis, but the patients with stable disease ≥6 months remain of interest.

Original languageEnglish (US)
Pages (from-to)37-41
Number of pages5
JournalJournal of Interferon and Cytokine Research
Issue number1
Publication statusPublished - Jan 2004


ASJC Scopus subject areas

  • Immunology
  • Virology
  • Cell Biology

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