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news.Vion Pharmaceuticals has started an investigator-sponsored Phase I/II clinical trial of its lead anticancer agent Cloretazine in combination with cytarabine in elderly patients with previously untreated acute myelogenous leukemia and high-risk myelodysplastic syndromes.
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The objectives of the trial are to define the maximum tolerated dose (MTD) of Cloretazine (VNP40101M) when given in combination with cytarabine to acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS) patients over the age of 60, and to evaluate this combination further for safety and efficacy in a larger cohort of patients.
Cloretazine (VNP40101M) will be given as a 30 to 60 minute infusion on day one approximately three to four hours after the start of the cytarabine infusion. Cytarabine will be administered as a continuous infusion of 100mg/m2/day for seven days. In the Phase I portion of the study, dose escalation will be done in cohorts of at least three patients and the maximum tolerated dose (MTD) identified in the Phase I segment will be used in the Phase II segment of the study.
The trial is being conducted under the direction of Ellen Ritchie, at the Weill-Cornell Medical College in New York City. Co- investigators for the study are Eric Feldman, and Gail Roboz.