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www.fdanews.com/articles/71036-vion-initates-trial-of-cloretazine-in-pediatric-brain-tumors

Vion Initates Trial of Cloretazine in Pediatric Brain Tumors

April 13, 2005

Vion Pharmaceuticals has announced that a Phase I trial of its anticancer agent Cloretazine (VNP40101M) in pediatric brain tumors had been initiated by the Pediatric Brain Tumor Consortium.

The trial will evaluate the maximum-tolerated dose (MTD) and dose-limiting toxicities of Cloretazine (VNP40101M) administered daily for five consecutive days every six weeks in children with recurrent, progressive or refractory primary brain tumors.

The MTD will be estimated in two strata: (1) patients who receive no prior radiation or local radiation only and/or less than or equal to two prior myelosuppressive chemotherapy or biological therapy regimens, and (2) patients who received prior craniospinal radiation, high-dose chemotherapy, and/or greater than two prior myelosuppressive chemotherapy or biological therapy regimens.