Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187174
• Other study ID #: RAD001
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: March 3, 2015
• Start date: October 2004
• Est. completion date: October 2008

Study information

• Verified date: December 2009
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Everolimus
The drug is given orally in 28 day courses.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   St. Jude Children's Research Hospital