Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
Phase 1
Completed
- Conditions
- TumorsRhabdomyosarcomaSarcoma, Soft TissueBrain Tumors
- Interventions
- Registration Number
- NCT00187174
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
- Adequate performance status
- Adequate bone marrow, kidney, heart, and liver function
Exclusion Criteria
- Must not be receiving concomitant anti-cancer treatment
- Must not be pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 Everolimus -
- Primary Outcome Measures
Name Time Method 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 Within 30 days per subject
- Secondary Outcome Measures
Name Time Method To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001 Within 30 days per subject
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States