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news.Research organization The Pediatric Brain Tumor Consortium has initiated a phase I trial of Vion Pharmaceuticals' anticancer agent, Cloretazine, in pediatric brain tumors.
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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.
This will be the first study of the drug, which is a novel alkylating agent that has achieved promising preclinical results, in children.
“Children with recurrent malignant brain tumors have an extremely poor prognosis,” said Dr Sridharan Gururangan, director of pediatric clinical services at The Brain Tumor Center at Duke University Medical Center. “Treatment failure is usually due to the development of drug resistance in tumors. New drugs with novel mechanisms of action are required to circumvent this resistance.”
Cloretazine is being evaluated in five clinical trials, including a phase III trial in combination with Ara-C in relapsed acute myeloid leukemia. It is one of two Vion agents in clinical trials, with the other being Triapine, which is being evaluated in combination with gemcitabine (Eli Lilly’s Gemzar) in a phase II trial in pancreatic cancer and several additional phase I and II trials.