Brain Tumors, Rhabdomyosarcoma, Sarcoma, Soft Tissue, Tumors
Conditions
Keywords
Brain tumors, Soft Tissue Sarcomas, Refractory solid tumors, Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
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.
Interventions
DRUGEverolimus
The drug is given orally in 28 day courses.
Sponsors
Novartis
St. Jude Children's Research Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed