Glioma Clinical Trial
Official title:
A Phase II Study of Everolimus (RAD001) for Children With Chemotherapy and/or Radiation-Refractory Progressive or Recurrent Low-Grade Gliomas
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.
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).
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