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Kinase Inhibitor
Selumetinib for Pediatric Brain Cancer
Phase 1 & 2
Waitlist Available
Led By Jason R Fangusaro
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- > 15 years: 1.5 mg/dL
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73m^2 or a serum creatinine based on age as follows (within 14 days of registration and within 7 days of the start of treatment):
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for young patients aged 3-21 with recurrent or refractory low grade glioma, including various types of brain tumors like astrocytoma. Participants must have specific tumor characteristics confirmed by recent tests and be willing to provide tissue samples for genetic testing.
What is being tested?
The trial is examining the effects and optimal dosage of Selumetinib, a drug intended to inhibit tumor growth by blocking enzymes necessary for cell proliferation. It's designed as a phase I/II study to determine side effects and effectiveness in children and young adults.
What are the potential side effects?
Selumetinib may cause side effects such as fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, visual changes, muscle weakness, heart issues (like hypertension), blood count abnormalities which could lead to increased risk of infections or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function test result is better than 1.5 mg/dL.
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My kidney function tests are within the required range.
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I am over 18 and my blood pressure is below 140/90 mm Hg.
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I am not pregnant or breastfeeding and have a negative pregnancy test.
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I can swallow pills.
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My kidney function is within the required range for my age.
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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.
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My cancer can be measured in two different directions.
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My child's blood pressure is within the normal range for their age, height, and gender.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease stabilization rates (re-treatment study)
Maximum tolerated dose and recommended phase 2 dose of selumetinib determined by dose-limiting toxicities (phase I)
Objective response (objective response = complete response + partial response) (re-treatment study)
+1 moreSecondary study objectives
Plasma drug concentrations and pharmacokinetic parameters (Phase I)
Presence or absence of BRAF V600E mutations or BRAF KIAA1549 fusion (phase II)
Progression-free survival (retreatment study)
+1 moreAwards & 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: Treatment (selumetinib)Experimental Treatment2 Interventions
Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience a sustained objective response from selumetinib on the phase I or phase II portions of the trial, and who have completed 2 years of treatment and stopped study drug may be enrolled on the re-treatment study after progression/recurrence. Patients in the re-treatment study may continue treatment indefinitely in the absence of disease progression or unacceptable toxicities. Patients undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Selumetinib
2010
Completed Phase 2
~2080
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,731 Total Patients Enrolled
Jason R FangusaroPrincipal InvestigatorPediatric Brain Tumor Consortium
2 Previous Clinical Trials
319 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selumetinib)
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.
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