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CCI-779 in metastatic melanoma
A Phase II trial of the California Cancer Consortium
Article first published online: 8 JUL 2005
Copyright © 2005 American Cancer Society
Volume 104, Issue 5, pages 1045–1048, 1 September 2005
How to Cite
Margolin, K., Longmate, J., Baratta, T., Synold, T., Christensen, S., Weber, J., Gajewski, T., Quirt, I. and Doroshow, J. H. (2005), CCI-779 in metastatic melanoma. Cancer, 104: 1045–1048. doi: 10.1002/cncr.21265
- Issue published online: 17 AUG 2005
- Article first published online: 8 JUL 2005
- Manuscript Revised: 7 APR 2005
- Manuscript Accepted: 7 APR 2005
- Manuscript Received: 15 JUN 2004
- National Cancer Institute. Grant Number: N01 CM-07003-74
- rapamycin analog;
- metastatic melanoma
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, thrombocytopenia, asthenia, and follicular dermatitis.
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.
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.
CCI-779 was not sufficiently active in melanoma to warrant further testing as a single agent. Cancer 2005. © 2005 American Cancer Society.