NCT00187174

Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Although a Phase II portion of this study was planned, it was never initiated.

Conditions

• Tumors
• Brain Tumors
• Rhabdomyosarcoma
• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Everolimus	The drug is given orally in 28 day courses.

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-16
• Last updated: 2015-03-04

Locations

1 site across 1 country: United States