Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to conventional therapy, or with no known effective therapy, will be treated. Experiments in the laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive cell multiplication needs to be stopped. The drug has been tested in adult cancer patients and has been well tolerated by subjects in these studies. It is experimental and, therefore, available in clinical trials.
Sarcoma, Soft Tissue
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors|
- To find the highest dose of RAD001 that can be given to children with refractory or relapsing solid tumors, leukemias, or brain tumors without causing severe side effects [ Time Frame: Within 30 days per subject ] [ Designated as safety issue: Yes ]
- To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001 [ Time Frame: Within 30 days per subject ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2004|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Experimental: Phase 1||
The drug is given orally in 28 day courses.
Although a Phase II portion of this study was planned, it was never initiated.
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Wayne L Furman, MD||St. Jude Children's Research Hospital|