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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not pregnant or breastfeeding.
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My lung function tests are normal for my age.
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I received my last strong cancer treatment over 3 weeks ago, or 6 weeks for a specific type.
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I am between 3 and 21 years old.
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My brain tumor is a grade I or II astrocytoma and is growing.
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I finished my brain or spinal cord radiation treatment over 12 weeks ago.
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I can do most activities but may need help.
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My blood, liver, kidney, and cholesterol levels are all within a healthy range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Progression Free Survival at 6 Months
Secondary outcome measures
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 • NCT0209610720%
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
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
Find a Location
Who is running the clinical trial?
The Pediatric Low Grade Astrocytoma (PLGA) FoundationOTHER
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,406 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,285 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I can provide tissue samples from when my cancer was first diagnosed or came back.I do not have any uncontrolled illnesses.I have been treated with an mTOR inhibitor before.My lung function tests are normal for my age.I have had treatments for cancer relapses before this one.I received my last strong cancer treatment over 3 weeks ago, or 6 weeks for a specific type.I am between 3 and 21 years old.I am not on medications that could affect the study results.I am on long-term steroids or other drugs that weaken my immune system.I am allergic to everolimus or similar medications.I have been cancer-free and off treatment for any other cancer for at least 3 years.I have not had any live vaccines in the week before or during the study.I do not have Hepatitis B or C.I can attend all required follow-up visits.My brain tumor is a grade I or II astrocytoma and is growing.I finished my brain or spinal cord radiation treatment over 12 weeks ago.I agree to use birth control during the study.I can do most activities but may need help.I have a tumor in my spinal cord.I can swallow pills.I have a stomach or intestine problem that affects how my body absorbs medication.I have a known history of being HIV positive.My blood, liver, kidney, and cholesterol levels are all within a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: Everolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have any age restrictions?
"This research is enrolling individuals who were born no earlier than 3 years ago, and no later than 21 years ago."
Answered by AI
Could I take part in this medical research if I qualify?
"This research is only interested in individuals that have glioma and are between the ages of 3-21. So far, 65 patients fit this criteria."
Answered by AI
What are the common indications for Everolimus?
"Everolimus has been shown to effectively treat kidney transplant rejection as well as waldenstrom macroglobulinemia, lung conditions, and advanced carcinoid tumors."
Answered by AI
Could you please detail the safety profile of Everolimus?
"There is some data supporting Everolimus' safety, but none suggesting it to be effective. It received a score of 2."
Answered by AI
Can you tell me if Everolimus has been featured in other research?
"Everolimus was first researched in 2008 at Sheba Medical Center. As of right now, 405 studies have been completed with 98 active clinical trials taking place - a majority of which are located in Seattle, Washington."
Answered by AI
At how many different sites is this research project being conducted?
"The trial is being conducted at the University of Washington in Seattle, WA, Johns Hopkins University in Baltimore, MD, and Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago, IL as well as 18 other medical facilities."
Answered by AI
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