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Selumetinib for Pediatric Brain Cancer
Study Summary
This trial is testing a new drug to treat young patients with brain cancer that has come back or does not respond to treatment. The drug may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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.Trial Design
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Who is running the clinical trial?
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- I haven't taken any growth factor medications for at least 1 or 2 weeks.My brain tumor is growing, came back, or is not responding to treatment, and it's not a pilocytic astrocytoma or optic pathway glioma but has a BRAF mutation.My low-grade glioma is worsening and has a BRAF mutation.My BRAF status has been tested at Brigham and Women's Hospital.My optic pathway glioma is getting worse or not responding to treatment.I have seizures that are not controlled by medication.I agree to sign a consent and provide tumor samples for BRAF testing.I have been treated with a BRAF inhibitor before, but not sorafenib.My neurological symptoms have been stable for at least a week.My body surface area is at least 0.55 square meters.I do not have any serious illnesses that could affect the study.My tumor was tested for BRAF mutations, and I may need to send more samples for confirmation.My condition is a non-NF1 related low grade glioma, not including pilocytic astrocytoma or optic pathway glioma.I am not currently taking any cancer treatment or experimental drugs.I am between 3 and 21 years old.My tumor type qualifies me for a specific part of the study.I had my last chemo that lowers blood cell counts 3 weeks ago, or 6 weeks ago if it was a specific type.My brain tumor is not related to NF-1 and is not in the optic pathway.My tumor is a type of brain cancer not linked to NF-1 and has been tested for BRAF.I have NF-1 and my low grade glioma is growing, coming back, or not responding to treatment.I have NF-1 with a low grade glioma that is getting worse or not responding to treatment.My tumor is a specific type of brain cancer without certain genetic changes and I have tissue samples available.My cancer is a type of brain tumor not linked to NF1 and is getting worse or has come back.I have a low grade glioma (not in the optic pathway) that is getting worse, coming back, or not responding to treatment, and my tumor can be tested for BRAF but doesn't fit other specific groups due to technical issues.I've had cancer treatment before and have recovered from its immediate side effects.I received my last chemotherapy dose more than 3 weeks ago, or more than 6 weeks ago if it was nitrosourea.I received my last biologic treatment more than a week ago.I have waited long enough after my last biologic treatment to join.It's been long enough since my last monoclonal antibody treatment.I am undergoing or have completed radiation therapy.I had my last brain and spinal cord radiation over 3 months ago.My last radiation treatment was over a year ago.My blood pressure is normal for my age, height, and gender.My kidney function test result is better than 1.5 mg/dL.I received my last biologic or antibody treatment more than a week ago.I must receive radiation therapy.My last radiation treatment was over a year ago.I had my last brain and spine radiation treatment over 3 months ago.I haven't taken any growth factor medications for at least 1 week.I have a condition that increases my risk of heart rhythm problems.I have a specific type of brain tumor (not NF-1 related) with a BRAF mutation but not in the optic pathway.My hemoglobin level is at least 8 g/dL.My bilirubin levels are within normal range for my age.My kidney function tests are within the required range.I have been on a stable or decreasing dose of dexamethasone for at least a week.I have been on a stable or decreasing dose of dexamethasone for at least 1 week.I can swallow pills.I can care for myself but may need occasional help.My kidney function is within the required range for my age.I have high blood pressure.My blood pressure is within the normal range for my age, height, and gender.I've been treated with PBTC-029 or PBTC-029B for at least 12 courses with stable disease or had a good response but treated for less than 12 courses.My low-grade glioma has worsened after AZD6244 treatment and possibly other treatments.My cancer can be measured in two different directions.I have recovered from side effects of my previous cancer treatments.I am not pregnant or breastfeeding and have a negative pregnancy test.I am over 18 and my blood pressure is below 140/90 mm Hg.I am using or willing to use birth control during and after the study as required.My condition does not match the specified criteria.My eligibility scans were done within the last 3 weeks.I have previously used MEK inhibitors for treatment.I have been treated with a MEK inhibitor that is not AZD6244.I am taking medication that can affect my heart's rhythm.I have at least one cancer lesion that can be measured in two different directions.My child's blood pressure is within the normal range for their age, height, and gender.
- Group 1: Treatment (selumetinib)
- 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
Is participation in this experiment available for individuals now?
"According to the clinicaltrials.gov platform, this medical trial is not actively recruiting patients at present. The study was first posted on April 19th 2010 and last modified on November 1st 2022; nevertheless, there are 1419 other trials with open enrollment presently."
To what extent does the age threshold of 80 years restrict participation in this clinical research?
"This research is actively recruiting participants who are between 3 and 21 years of age."
What are the predicted results of this clinical experiment?
"This study over 48 weeks will primarily be evaluating the maimum tolerated dose and recommended phase 2 dose of selumetinib based on any reported toxicities. Secondary objectives include assessing BRAF V600E mutations or BRAF KIAA1549 fusion via immunohistochemistry and fluorescence in situ hybridization, analyzing progression-free survival with Kaplan Meier plots, log rank tests, or Cox regression models (if applicable), as well as measuring plasma drug concentrations and associated pharmacokinetic parameters."
Have any other experiments been conducted that focused on Pharmacological Study?
"First conducted in 2007 at a research facility, Pharmacological Study has since been subject to 646 clinical trials. At present, 34 studies are ongoing with many of them hosted by Washington D.C.."
How many distinct locations are hosting this experiment?
"17 patient enrolment sites are currently participating in this research endeavour, including Children's National Medical Center of Washington D.C., the Children's Memorial Outpatient Centre in Lincoln Park, Chicago, and the Children's Hospital Colorado based in Aurora; other locations have been enlisted as well."
Has this specific clinical trial ever been implemented before?
"Pharmaceutical Study has been the object of research since 2007, when it was first trialled by AstraZeneca. After this initial 58-person study in 2007, Phase 1 drug approval for Pharmacological Study was granted. There are currently 34 trials analysing its effects running across 156 cities and 33 countries globally."
What is the current participant capacity of this experiment?
"Unfortunately, no more participants are being accepted for this trial. It ran from April 19th 2010 to November 1st 2022 and is now closed. However, patients with refractory neurofibromatosis type 1 have 1385 different clinical trials available to them at present, along with 34 options concerning pharmacological studies."
Who is qualified to enlist in this experiment?
"This clinical trial seeks to enrol 220 minors, aged 3-21 suffering from resistant neurofibromatosis type 1. Other necessary prerequisites for those wishing to participate include: Imaging evaluations must be conducted within three weeks of registration and other eligibility tests done within two weeks, Therapy is expected to commence within 7 calendar days of signing up for the study; Laboratory values should not exceed seven days prior to therapy start date. If criteria are still unmet after a re-examination conducted 48 hours before treatment commences, they will no longer qualify as participants in this research endeavour."
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