CCI-779 in metastatic melanoma: A phase II trial of the California cancer consortium

Kim Margolin, Jeffrey Longmate, Tracey Baratta, Tim Synold, Scott D Christensen, Jeffrey Weber, Thomas Gajewski, Ian Quirt, James H. Doroshow

Research output: Contribution to journalArticlepeer-review

224 Scopus citations


BACKGROUND. CCI-779 is an analog of the immunosuppressive agent, rapamycin, that has demonstrated activity against melanoma in preclinical models and shown clinical benefit in patients with breast and renal carcinoma. CCI-779 is not immunosuppressive when administered on an intermittent schedule, and its toxicity is modest, consisting of nausea, diarrhea, hypertriglyceridemia, thromhocytopenia, asthenia, and follicular dermatitis. METHODS. The current trial was designed to detect a median time to disease progression of >18 weeks in patients with metastatic melanoma treated with a 250-mg weekly dose of CCI-779 administered intravenously after diphenhydramine premedication. Patients with measurable disease, no more than one previous chemotherapy regimen for metastatic disease, and normal organ function were eligible, and patients with central nervous system involvement, P450-inducing or P450-suppressing drugs, or hypertriglyceridemia were excluded. RESULTS. Thirty-three patients (21 males) were treated, 21 of whom had been treated previously with chemotherapy and/or biologic agents for advanced-stage disease. One patient had a partial response lasting 2 months. The median time to disease progression and overall survival were 10 weeks and 5 months, respectively. Toxicity was mild and predominantly mucocutaneous (stomatitis, diarrhea, and rash). Hyperlipidemia was cumulative and was managed with lipid-lowering agents. CONCLUSIONS. CCI-779 was not sufficiently active in melanoma to warrant further testing as a single agent.

Original languageEnglish (US)
Pages (from-to)1045-1048
Number of pages4
Issue number5
StatePublished - Sep 1 2005


  • CCI-779
  • Metastatic melanoma
  • Rapamycin analog

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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