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Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187174
First Posted: September 16, 2005
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  Purpose
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.

Condition Intervention Phase
Tumors Brain Tumors Rhabdomyosarcoma Sarcoma, Soft Tissue Drug: Everolimus Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

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 [ Time Frame: Within 30 days per subject ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: October 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 Drug: Everolimus
The drug is given orally in 28 day courses.

Detailed Description:
Although a Phase II portion of this study was planned, it was never initiated.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187174


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Novartis
Investigators
Principal Investigator: Wayne L Furman, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187174     History of Changes
Other Study ID Numbers: RAD001
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: March 4, 2015
Last Verified: December 2009

Keywords provided by St. Jude Children's Research Hospital:
Brain tumors
Soft Tissue Sarcomas
Refractory solid tumors
Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Additional relevant MeSH terms:
Neoplasms
Sarcoma
Brain Neoplasms
Rhabdomyosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents