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Trametinib for Pediatric Brain Tumor
Study Summary
This trial will study the response rate of pediatric brain tumors to oral administration of the drug trametinib. A total of 150 patients will be recruited, and the study will also explore the molecular mechanisms behind tumor development, progression and resistance to treatment.
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 2021 Phase 2 trial • 206 Patients • NCT02034110Trial Design
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Who is running the clinical trial?
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- I have a specific type of progressing brain tumor or nerve tumor.I am between 1 month and 25 years old and starting trametinib treatment.My condition worsened while on a MEK inhibitor treatment.I had major surgery less than 2 weeks before starting trametinib.I do not have severe illnesses like uncontrolled liver disease, HIV, or hepatitis.I can enroll without tumor tissue if I have NF1 and LGG or PN and no surgery was done.I have tried at least one treatment like chemotherapy or radiation, but not for plexiform neurofibroma.I have recovered from the side effects of my previous cancer treatments.I can do most activities but may need help.My organ and bone marrow functions are normal.I can swallow and keep down pills without significant stomach issues affecting absorption.My tumor has a positive BRAF V600E mutation.My heart's pumping ability is below normal, or I have a long QT interval.I have another cancer, but it's not currently serious or needing treatment.
- Group 1: Progressing/refractory low grade-glioma, KIAA1549-BRAF fusion
- Group 2: Neurofibromatosis Type 1 (NF1) with Plexiform Neurofibroma
- Group 3: Neurofibromatosis Type 1 (NF1) with low-grade glioma
- Group 4: Progressing/Refractory central nervous system (CNS) glioma.
- 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
Does this research include young people in the target age group?
"Individuals that meet the age criteria of being over 1 month old but younger than 25 years are eligible for this trial."
What are some of the known side effects of Trametinib?
"Trametinib's safety falls in the middle of our 1-to-3 scale at a 2. This is because, while there is some data suggesting that it is safe, there is no evidence that it is effective."
Are there other instances of Trametinib being studied in a clinical setting?
"As of now, there are 96 ongoing clinical trials for Trametinib with 6 being in Phase 3. The largest amount of these trials are taking place in Saint Louis, Missouri; however, there are 5799 total locations running trials for Trametinib."
How many different hospitals are conducting this study?
"Presently, there are 7 active clinical trial sites. They are situated in cities like Calgary, Quebec City and Halifax. It is best to select the closest location to you to limit travel time if you decide to participate."
Are investigators actively working to find more participants for this clinical trial?
"According to the latest information on clinicaltrials.gov, this trial is not recruiting patients at this time. The study was first posted on 8/16/2018 and updated as recently as 10/25/2022; however, there are over 500 other trials that are actively looking for participants."
How many people are included in this clinical trial at most?
"As of October 25th, 2022, this particular clinical trial is no longer recruiting patients. It was initially uploaded to the website on August 16th, 2018. For anyone still seeking medical trials to participate in, there are 413 studies for glioma and 96 for Trametinib that are currently enrolling patients."
Who does this trial seek as participants?
"This clinical trial is recruiting 114 people with glioma who are between 1 month and 25 years old. The following criteria must be met: Assent from minor participants should be obtained per local laws and regulations and should be documented in accordance with local requirements, 8. Prior therapy Participants must have failed at least one line of treatment including chemotherapy and/or radiation therapy except for plexiform neurofibroma (since there is no recognized standard treatment for his tumor)., Age Patient must be aged ≥ 1 month (corrected age) to ≤ 25 years when starting trametinib., Study group Participants must belong to one of"
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