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Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187174
First received: September 13, 2005
Last updated: December 3, 2009
Last verified: December 2009
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
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

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Wayne L. Furman, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187174     History of Changes
Other Study ID Numbers: RAD001
Study First Received: September 13, 2005
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014