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OpenTrials
Completed

NCT Number: NCT00187174

Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

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.

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Key information

Conditions

Tumors Brain Diseases Brain Neoplasms Brain Tumors Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Rhabdomyosarcoma Sarcoma Sarcoma, Soft Tissue

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

The drug is given orally in 28 day courses.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • Novartis

Registry information

Official study title

Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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