This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The objectives of the Dose Finding (Continual Reassessment Method (CRM)) phase of this clinical trial are 1) To determine the maximum tolerated dose of BMS-247550 when administered to adults with recurrent malignant gliomas, receiving (Group A) or not receiving (Group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. 2) To describe the pharmacokinetics of this route of administration, measuring BMS-247550, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants , on the pharmacokinetics . The objectives for the Safety/Efficacy at Maximum Tolerated Dose (MTD) phase are 1) To determine the response rate of adult patients with recurrent glioma to BMS-247550 administered at the MTD. 2) To describe the toxicity associated with this regimen in adult patients with recurrent malignant gliomas. Secondary Objective a) To determine the percent of patients with 6 month progression free survival, duration of progression free survival and survival associated with this therapy in adult patients with recurrent malignant gliomas. BMS-247550 is a methyl, semi-synthetic analog of the natural product epothilone B produced by Bristol-Myers Squibb. This compound was selected for clinical development based on impressive preclinical activity against paclitaxel-sensitive and -resistant cell lines. Objective responses have been observed in patients with breast and cervical cancer; with > 50% reduction in CA125 in two of 12 patients with advanced ovarian cancer (all breast, cervical and ovary cancer patients had prior taxane therapy).
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