Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 1

Conditions: Tumors; Rhabdomyosarcoma; Brain Tumors; Sarcoma, Soft Tissue

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00187174

RAD001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 41 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Phase 1

Experimental group

Treatment:

Drug: Everolimus