NCT00187174

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 4, 2015

Status Verified

December 1, 2009

Enrollment Period

4 years

First QC Date

September 13, 2005

Last Update Submit

March 3, 2015

Conditions

TumorsBrain TumorsRhabdomyosarcomaSarcoma, Soft Tissue

Keywords

Brain tumorsSoft Tissue SarcomasRefractory solid tumorsRecurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Outcome Measures

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

    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

    Within 30 days per subject

Study Arms (1)

Phase 1

EXPERIMENTAL
Drug: Everolimus

Interventions

EverolimusDRUG

The drug is given orally in 28 day courses.

Phase 1

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adequate performance status
  • Adequate bone marrow, kidney, heart, and liver function

You may not qualify if:

  • Must not be receiving concomitant anti-cancer treatment
  • Must not be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsBrain NeoplasmsRhabdomyosarcomaSarcomaRecurrence

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Wayne L Furman, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 4, 2015

Record last verified: 2009-12

Locations

US(1)