Introduction: CI-980 is a novel chemotherapeutic agent that inhibits polyme
rization of tubulin. Preclinical studies have indicated a high level activi
ty of this agent against various tumor cell lines. Methods: 13 malignant me
lanoma patients who had failed prior chemotherapy and/or immunotherapy and
13 hormone refractory prostate cancer patients, including 4 who had receive
d prior chemotherapy, were treated in 2 separate NCI-supported clinical tri
als. Subjects received a recommended phase II dose of CI-980 of 4.5 mg/m(2)
/day by continuous infusion for 72 hours every 3 weeks. Results: No activit
y was seen in either study. Toxicity was tolerable with neutropenia being t
he most common, significant toxicity. Among the melanoma patients, 15% and
31% developed grade 3 and grade 4 neutropenia, while 7% and 38% of the pros
tate patients developed grade 3 and grade 4 neutropenia, respectively. Conc
lusions: CI-980 at this dose and schedule is ineffective against malignant
melanoma and hormone refractory prostate cancer.