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

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.

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

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