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mTOR inhibitor

Everolimus for Ependymoma

Phase 2
Waitlist Available
Led By Daniel C Bowers, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will evaluate the anti-tumor activity of Everolimus in children with recurrent or progressive ependymoma.

Eligible Conditions
  • Recurrent Childhood Ependymoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (Complete Response Rate and Partial Response Rate) following treatment with everolimus for children with recurrent or progressive ependymomas.
Secondary outcome measures
Correlation of tumor Objective Response Rate to established immunohistochemical biomarkers of mTOR pathway activation, including pS6, p4EBP1, pPRAS40, pp70S6K and PTEN.
Duration of response following treatment with everolimus for children with recurrent or progressive ependymomas.
Event free survival (EFS) following treatment with everolimus for children with recurrent or progressive ependymomas.
+2 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107
20%
Hospitalization
20%
Immunosuppression held or modified
10%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Low Intensity Tacrolimus

Trial Design

1Treatment groups
Experimental Treatment
Group I: EverolimusExperimental Treatment1 Intervention
The recommended dose of Everolimus is 4.5 mg/m2/dose, once daily for up to 2 years, until disease progression or unacceptable toxicity occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,788 Total Patients Enrolled
Daniel C Bowers, MDPrincipal InvestigatorUT Southwestern Medical Center at Dallas, Dallas, TX
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian sites participating in this research?

"4 hospitals are running this trial: UT Southwestern Medical Center / Children's Medical Center in Dallas, New york University Stephen D. Hassenfeld Children's Center for Cancer & Blood Disorders in New York, Baylor College of Medicine / Texas Children's Hospital in Houston. There are also 4 other locations with participating sites."

Answered by AI

How large is the pool of test subjects for this clinical trial?

"Presently, this trial is not recruiting patients. The study was first posted on February 1st 2015 and the most recent edit occurred on October 29th 20202. However, there are presently 1107 studies actively recruiting participants with recurrent childhood ependymoma and 98 trials for Everolimus enrolling patients."

Answered by AI

When was Everolimus cleared by the FDA?

"While Phase 2 trials don't provide data supporting a medication's efficacy, there is some clinical evidence indicating that Everolimus is safe. This resulted in a score of 2."

Answered by AI

Are participants in this clinical trial restricted to a certain age group?

"In order to participate in this clinical trial, applicants must be aged 2-21. Out of the 1249 total clinical trials, 207 are for those under 18 and 1042 are for patients 65 and older."

Answered by AI

Are there any patients enrolled in this clinical trial at the moment?

"Unfortunately, this particular trial is not looking for new patients at the moment. The study was originally posted on February 1st, 2015 and was last updated on October 29th, 2022. There are 1205 other trials that might be a better fit for you."

Answered by AI

Are there any precedents for using Everolimus in a clinical setting?

"The first clinical trial of everolimus took place in 2008 at Sheba Medical Center. Since then, there have been a total of 405 completed trials and 98 ongoing studies. Some of the active recruitment drives for these trials are based out of Dallas, Texas."

Answered by AI

For what purpose is Everolimus most regularly prescribed?

"Everolimus can help patients who have received a kidney transplant, have waldenstrom macroglobulinemia, or are suffering from lung rejection."

Answered by AI

How can I get involved with this research?

"This particular clinical trial is only for children and young adults aged 2-21 who have recurrent childhood ependymoma. There are still 11 available spots in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Everolimus for Children With Recurrent or Progressive Ependymoma
Daniel Bowers 2015. "Everolimus for Children With Recurrent or Progressive Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02155920.
~1 spots leftby Apr 2025
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