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Clinical Trial Summary

The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a drug that may act directly on tumor cells by inhibiting tumor cell growth and proliferation.


Clinical Trial Description

OBJECTIVES:

Primary

- To determine the response of children with chemotherapy-refractory or progressive low-grade gliomas to everolimus. Secondary

- To evaluate pharmacogenetic polymorphisms of cytochrome P450 3A4 & 3A5 alleles and P-glycoprotein/MDR for their influence on the metabolism of everolimus in this patient population.

- To evaluate the role of Apolipoprotein E genotypes as predictors for development of hyperlipidemia during therapy with everolimus.

- To assess preliminary correlations of response with changes in pharmacodynamic parameters including p70s6 kinase activity in peripheral blood mononuclear cells.

- To describe the toxicity of everolimus when administered to this patient population.

- To characterize the pharmacokinetic profile of everolimus when administered to this patient population.

STATISTICAL DESIGN:

This study used a one-stage design to evaluate response to everolimus. If at least 3 responders are observed in 20 evaluable patients, then everolimus will be considered promising. If the true response rate is 5% (null hypothesis), the chance of concluding the treatment is active is 0.08 (Type I error). If the true response rate is 25% (alternative hypothesis), the chance of concluding the treatment is active is 0.91 (power). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00782626
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date June 2009
Completion date August 2012

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