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Brief Title: Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas
Official Title: A Phase II Study of Everolimus (RAD001) for Children With Chemotherapy and/or Radiation-Refractory Progressive or Recurrent Low-Grade Gliomas
Study ID: NCT00782626
Brief 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.
Detailed 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).
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Phoenix Children's Hospital Center for Cancer and Blood Disorders, Phoenix, Arizona, United States
The Children's Hospital, Denver, Colorado, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
John Hopkins Medical Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
New York University, New York, New York, United States
Memorial Sloan-Kettering Cancer Institute, New York, New York, United States
Doernbecher Children's Hospital Oregon Health & Science University, Portland, Oregon, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Karen Wright, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR