← Back to Search

mTOR inhibitor

Everolimus for Pediatric Brain Cancer

Phase 2

Waitlist Available

Led By Sabine Mueller, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients of child-bearing potential must not be breastfeeding or pregnant

Patients must have normal pulmonary function testing for age based on pulse oximetry

Must not have

Uncontrolled intercurrent illness

Patients who have been previously treated with an mTOR inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of the drug everolimus in children with a type of brain cancer called low-grade glioma.

Who is the study for?

This trial is for children aged 3-21 with recurrent or progressive low-grade glioma, a type of brain tumor. They must have measurable disease on MRI, be able to swallow pills, and have proper organ function. Previous treatments are allowed if enough time has passed. Girls who can get pregnant and boys must use birth control during the study.

What is being tested?

The trial is testing Everolimus in kids with specific types of low-grade gliomas that came back or got worse after treatment. It's an open-label study, meaning everyone knows they're getting Everolimus, and it looks at how well it works in these cases.

What are the potential side effects?

Everolimus may cause mouth sores, infections due to a drop in blood cell counts, lung problems like coughing or shortness of breath, changes in blood sugar levels (like diabetes), kidney issues, high cholesterol or triglycerides levels which could affect heart health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant or breastfeeding.

Select...

My lung function tests are normal for my age.

Select...

I received my last strong cancer treatment over 3 weeks ago, or 6 weeks for a specific type.

Select...

I am between 3 and 21 years old.

Select...

My brain tumor is a grade I or II astrocytoma and is growing.

Select...

I finished my brain or spinal cord radiation treatment over 12 weeks ago.

Select...

I can do most activities but may need help.

Select...

My blood, liver, kidney, and cholesterol levels are all within a healthy range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any uncontrolled illnesses.

Select...

I have been treated with an mTOR inhibitor before.

Select...

I am on long-term steroids or other drugs that weaken my immune system.

Select...

I am allergic to everolimus or similar medications.

Select...

I do not have Hepatitis B or C.

Select...

I have a tumor in my spinal cord.

Select...

I have a stomach or intestine problem that affects how my body absorbs medication.

Select...

I have a known history of being HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Progression Free Survival at 6 Months

Secondary study objectives

Median Overall Survival in Recurrent Pediatric LGGs

Median Progression Free Survival in Recurrent Pediatric Low-grade Glioma (LGGs)

Proportion of Participants With Objective Response

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%

Study treatment Arm

Standard of Care

Low Intensity Tacrolimus

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EverolimusExperimental Treatment1 Intervention

Everolimus tablet will be taken daily by mouth with water. Twenty-eight days will constitute one course and subsequent courses will immediately follow with no break in the administration of the drug. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Patients will also be provided with a drug diary for everolimus. The maximum time on study is 24-months, but if there is no disease progression or adverse events, the patient may speak with a doctor about continuing the treatment off-study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

2010

Completed Phase 4

~1510

0 / 16Eligibility criteria met