A Phase II Study of Everolimus (RAD001) for Children With Chemotherapy and/or Radiation-Refractory Progressive or Recurrent Low-Grade Gliomas
- Participants will be given a study medication-dosing calendar for each treatment
course. Each treatment course lasts 4 weeks. Participants can remain on study for 12
courses (48 weeks). Participants will take RAD001 tablets orally once a day. If
participants cannot swallow tablets, participants will be instructed on how to create a
liquid preparation.
- During all treatment courses participants will have a physical exam. Each treatment
course lasts 4 weeks. A medical history, urine test, blood tests, ECG and tumor imaging
using MRI and MR Perfusion and Diffusion will also be performed. Blood sampling for
RAD001 levels will be drawn weekly during the first course (4 weeks) of treatment and
then drawn once during subsequent courses thereafter.
- Pharmacokinetic studies will be done to see how the body absorbs, distributes and
excretes RAD001 by measuring the amount of the drug in the body at different time
points after taking the medication. Blood will be drawn one time before the start of
RAD001 therapy. Blood samples will also be drawn on Day 1 of cycle 2 at the following
times: before the Day 1 dose (pre-dose), 2, and 5 hours after the Day 1 dose of RAD001.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response of children with chemotherapy-refractory or progressive low-grade gliomas to RAD001.
3 years
No
Mark W. Kieran, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
09-001
NCT00782626
June 2009
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
New York University | New York, New York 10016 |
Children's Healthcare of Atlanta | Atlanta, Georgia 30342 |
The Children'S Hospital | Denver, Colorado 80218 |
University of Florida College of Medicine | Gainesville, Florida 32610 |
John Hopkins Medical Center | Baltimore, Maryland 21287 |
Memorial Sloan-Kettering Cancer Institute | New York, New York 10065 |
Phoenix Children's Hospital Center for Cancer and Blood Disorders | Phoenix, Arizona 85016 |
Doernbecher Children's Hospital Oregon Health & Science University | Portland, Oregon 97239 |