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Vemurafenib for Pediatric Brain Cancer
Study Summary
This trial is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory gliomas containing the BRAFV600E or BRAF Ins T mutation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 675 Patients • NCT01006980Trial Design
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Who is running the clinical trial?
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- I have had all suspicious skin lesions removed.My last radiation treatment was over 12 weeks ago.It has been over 6 months since my bone marrow transplant.I am not on any other cancer treatments or experimental drugs.I do not have uncontrolled seizures.I have previously used a BRAF inhibitor like vemurafenib.My heart's electrical activity is normal and I don't have severe heart failure.My neurological symptoms have been stable for at least a week.I can care for myself but may not be able to do active work.My blood tests show enough neutrophils, platelets, and hemoglobin.My liver tests are within the normal range for my age.My kidney function is good based on tests.I am under 25 and eligible for a specific part of the study based on earlier results.I can attend all required follow-up visits and tests.My BRAFV600E test result from UCSF is negative.I have been diagnosed with a type of brain tumor called glioma.My tumor has the BRAFV600E mutation as confirmed by UCSF.I am under 18 years old.I have had an MRI within the last two weeks.I have tried at least one treatment other than surgery for my condition without success.I had my last dose of strong chemotherapy 3 weeks ago, or 6 weeks ago if it was a specific type (nitrosourea).I've had no recent side effects from biologic therapy, last dose was over a week ago.I have been on a stable or decreasing dose of dexamethasone for at least a week.I am under 25 years old.I am under 25 years old and eligible for the pre-surgical group.I am taking medication that can affect my heart's rhythm.I am not pregnant or breastfeeding.My organ function tests are recent.I do not have any serious illnesses that could affect the study.
- Group 1: Vemurafenib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
For what conditions is Vemurafenib regularly prescribed?
"Vemurafenib is an accepted intervention for metastatic melanoma, non-small cell lung carcinoma and unreseptable cases of skin cancer."
Are there any vacant slots available for potential participants in this experiment?
"Per clinicaltrials.gov, this medical trial is no longer open for recruitment as the most recent edit to the listing occurred on August 9th 2022. However, there are an abundance of other trials actively searching for participants at present (1360)."
What other investigations involving Vemurafenib have been conducted?
"Currently, 44 investigations involving Vemurafenib are in progress. Of these studies, 3 have advanced to Phase 3 of the clinical trial process. Toronto, Ontario is a major centre for research into this medication; however there are 1626 other locations conducting trials with vemurafenib as well."
How many healthcare institutions are facilitating this experiment?
"This research is being administered at Mattel Children's Hospital UCLA in Los Angeles, Dana-Farber Cancer Institute in Boston and UCSF Medical Center-Mount Zion in San Francisco along with another 18 sites."
How many individuals are actively taking part in this research?
"This clinical trial is not actively recruiting right now; it was initially posted on April 29th, 2014 and the most recent update was recorded August 9th, 2022. For those seeking alternative studies, there are 1316 trials for relapse and 44 Vemurafenib-related investigations which require participants."
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