A phase II study of Irofulven (MGI 114) in patients with stage IV melanoma.
Sixteen patients with stage IV melanoma, who were heavily pretreated, received 11 mg/m2/day of intravenous Irofulven for five consecutive days every 28 days. There were no objective tumor responses, although one patient exhibited stable disease after 4 cycles. The most common toxicities were grade 1/2 nausea, vomiting, fatigue, anemia, and thrombocytopenia. One patient required a dose reduction for an elevated creatinine while another patient required cessation of treatment because of acute ataxia that may have been related to Irofulven. Based upon these data, Irofulven does not demonstrate significant antitumor activity to warrant further investigation in advanced melanoma.
Pierson
A Scott
AS
University of Colorado Cancer Center, Division of Medical Oncology, Anshutz Cancer Pavilion, Aurora 80010-0510, USA. aspierson@earthlink.com
Gibbs
Peter
P
Richards
Jon
J
Russ
Paul
P
Eckhardt
S Gail
SG
Gonzalez
Rene
R
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D012717:Sesquiterpenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000903:Antibiotics, Antineoplastic; D012717:Sesquiterpenes; C102714:irofulven; D007770:L-Lactate Dehydrogenase