Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

NCT ID: NCT00187174

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-10-31

Brief Summary

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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

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

Conditions

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Tumors Brain Tumors Rhabdomyosarcoma Sarcoma, Soft Tissue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

The drug is given orally in 28 day courses.

Interventions

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Everolimus

The drug is given orally in 28 day courses.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne L Furman, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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RAD001

Identifier Type: -

Identifier Source: org_study_id

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