Phase II trial of fotemustine in patients with metastatic malignant melanoma.

Abstract

Fotemustine is a novel chloroethylnitrosourea, that readily penetrates the blood brain barrier. Preliminary French studies reported encouraging results with fotemustine in patients with cerebral metastases of malignant melanoma. Thirty-one patients with histologically confirmed metastatic malignant melanoma were entered on a phase II trial. The treatment regimen consisted of fotemustine, administered intravenously as a rapid infusion, at a dose of 100 mg/m2 on day 1, 8 and 15 every 4 to 5 weeks. Objective response (CR + PR) was documented in 3 patients. Median time to treatment failure (TTF) was 44 days and median survival was 164 days. Life threatening toxicity did not occur; hematological toxicity and nausea and vomiting were the most common toxicities. Despite a somewhat disappointing response rate, objective responses were documented in patients with cerebral metastases. Since no other chemotherapeutic agent has shown therapeutic efficacy in cerebral metastases from malignant melanoma fotemustine therefore warrants further study.

• Authors: C I Falkson, G Falkson, H C Falkson
• Journal: Investigational new drugs (Invest New Drugs) Vol. 12 Issue 3 Pg. 251-4 ( 1994) ISSN: 0167-6997 [Print] United States
• PMID: 7896545 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Nitrosourea Compounds
• Organophosphorus Compounds
• fotemustine

Topics

• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Female
• Humans
• Leukopenia (chemically induced)
• Male
• Melanoma (drug therapy)
• Middle Aged
• Nausea (chemically induced)
• Neoplasm Metastasis
• Nitrosourea Compounds (adverse effects, therapeutic use)
• Organophosphorus Compounds (adverse effects, therapeutic use)
• Thrombocytopenia (chemically induced)
• Treatment Failure