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 Denmeade, Roberto Pili, Carol Ann Huff, Victoria Sinibaldi, Michael A. Carducci

Research output: Contribution to journalArticlepeer-review

10 Scopus citations


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
StatePublished - Jan 2004

ASJC Scopus subject areas

  • Immunology
  • Cell Biology
  • Virology


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