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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00187174
Other study ID # RAD001
Secondary ID
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


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
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