Trials / Completed
CompletedNCT00782626
Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas
A Phase II Study of Everolimus (RAD001) for Children With Chemotherapy and/or Radiation-Refractory Progressive or Recurrent Low-Grade Gliomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 3 Years – 21 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | everolimus |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2008-10-31
- Last updated
- 2018-08-15
- Results posted
- 2016-02-02
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00782626. Inclusion in this directory is not an endorsement.