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Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Primary Purpose

Tumors, Brain Tumors, Rhabdomyosarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Everolimus
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumors focused on measuring Brain tumors, Soft Tissue Sarcomas, Refractory solid tumors, Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001

Full Information

First Posted
September 13, 2005
Last Updated
March 3, 2015
Sponsor
St. Jude Children's Research Hospital
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00187174
Brief Title
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
Official Title
Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Brain Tumors, Rhabdomyosarcoma, Sarcoma, Soft Tissue
Keywords
Brain tumors, Soft Tissue Sarcomas, Refractory solid tumors, Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
The drug is given orally in 28 day courses.
Primary Outcome Measure Information:
Title
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
Time Frame
Within 30 days per subject
Secondary Outcome Measure Information:
Title
To find out if there are changes in the body's blood cells and tumor cells after treatment with RAD001
Time Frame
Within 30 days per subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne L Furman, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

Learn more about this trial

Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

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