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Alkylating Agent; Vinca Alkaloid
Selumetinib vs. Chemotherapy for Brain Cancer
Phase 3
Recruiting
Led By Peter M de Blank
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
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment): Age: Maximum Serum Creatinine (mg/dL) 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female) 10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female) >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing whether selumetinib is as effective as the standard treatment (carboplatin and vincristine) for low-grade glioma. It will also compare the side effects of the two treatments.
Who is the study for?
This trial is for children and young adults aged 2 to 21 with low-grade glioma brain tumors without certain genetic mutations or neurofibromatosis. They should not have had previous tumor treatments except surgery, must be able to swallow capsules, and meet specific health criteria like normal organ function tests.Check my eligibility
What is being tested?
The study compares the new drug Selumetinib against the standard chemotherapy drugs Carboplatin and Vincristine in treating low-grade gliomas. It aims to determine if Selumetinib is as effective as or better than standard treatment while also assessing its impact on quality of life.See study design
What are the potential side effects?
Selumetinib may cause heart issues, vision changes, bleeding problems, high blood pressure, infections due to low white blood cell counts, liver problems indicated by blood tests, and fatigue. Standard chemo can cause nausea, hair loss, nerve damage leading to numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range for my age and gender.
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My blood pressure is 130/80 mmHg or lower, with or without medication.
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I am between 2 and 21 years old.
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My body surface area is at least 0.5 square meters.
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My tumor is still present or growing after diagnosis and I haven't had any treatment yet.
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My tumor can be measured and is at least 1 cm^2 in size.
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My heart's pumping ability is normal or above normal.
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I can take care of myself but may not be able to do active work.
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I can swallow whole capsules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Change in executive function
Change in motor function
Change in quality of life (QOL)
+4 moreOther outcome measures
Change in QOL scores over time
Change in neurocognitive functioning scores over time
Side effects data
From 2020 Phase 2 trial • 8 Patients • NCT03040986100%
Aspartate aminotransferase increased
83%
Edema limbs
83%
Hypoalbuminemia
67%
Hypertension
67%
Fatigue
50%
Nausea
50%
Alkaline phosphatase increased
50%
Anorexia
50%
Anemia
50%
Abdominal pain
50%
Alanine aminotransferase increased
50%
Dyspnea
33%
Dizziness
33%
Generalized muscle weakness
33%
Hypocalcemia
33%
Hyponatremia
33%
Lymphocyte count decreased
33%
Rash maculo-papular
33%
Hypokalemia
33%
Bloating
33%
CPK increased
33%
Cough
33%
Creatinine increased
33%
Vomiting
17%
Alopecia
17%
Atelectasis
17%
Gallbladder infection
17%
Dysphagia
17%
Edema trunk
17%
Lipase increased
17%
Serum amylase increased
17%
Glucose intolerance
17%
Dry mouth
17%
Colonic obstruction
17%
Gallbladder obstruction
17%
Confusion
17%
Pancreatitis
17%
Diarrhea
17%
Dysgeusia
17%
Heart failure
17%
Ascites
17%
Hyperglycemia
17%
Weight loss
17%
White blood cell decreased
17%
Hypomagnesemia
17%
Hypotension
17%
Malaise
17%
Neck pain
17%
Pleural effusion
17%
Postnasal drip
17%
Renal and urinary disorders - Other, Dysuria
17%
Rash acneiform
17%
Neutrophil count decreased
17%
Paresthesia
17%
Peritoneal infection
17%
Back pain
17%
Biliary tract infection
17%
Blood bilirubin increased
17%
Fever
17%
Sore throat
17%
Urinary tract obstruction
17%
Musculoskeletal and connective tissue disorder - Other, muscle spasm
17%
Urine discoloration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 0: 75mg Selumetinib Sulfate Twice Daily
75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (selumetinib sulfate)Experimental Treatment5 Interventions
Patients receive selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.
Group II: Arm I (vincristine sulfate, carboplatin)Active Control6 Interventions
INDUCTION: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64, and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and magnetic resonance imaging (MRI) at baseline and end of induction.
MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15, and carboplatin IV over 60 minutes on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and undergo MRI at baseline, throughout the trial, and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Selumetinib Sulfate
2017
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,634 Total Patients Enrolled
Peter M de BlankPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had issues with my retina, like detachment or vein blockage.I have a genetic disorder linked to higher risk of heart disease.I am not pregnant and have taken a pregnancy test if capable of becoming pregnant.My kidney function is within the required range for my age and gender.I have not had surgery in the last 2 weeks, except for a biopsy, vascular access, or CSF procedure.I do not have uncontrolled glaucoma or eye pressure above 22 mmHg.I agree to use effective birth control during and for 12 weeks after the study.I have or had central serous retinopathy.My low-grade glioma does not have the BRAFV600E mutation and has only been treated with surgery.My cancer has spread or I have more than one primary low-grade glioma.My blood pressure is 130/80 mmHg or lower, with or without medication.My seizures are under control and haven't increased in the last 2 weeks.I've had a recent MRI of my brain or spine to check my cancer.My bilirubin levels are within the normal range for my age, or I have Gilbert's syndrome with acceptable bilirubin levels.I have had an eye exam within the last 4 weeks.I do not have any infections that are not under control.I am between 2 and 21 years old.My body surface area is at least 0.5 square meters.My MRI shows a tumor in a specific part of my brain stem, making me ineligible.I have not been treated for another cancer besides surgery in the past year.I have heart failure that causes me symptoms.I have heart issues that affect my daily activities.I have severe heart valve disease.I have a history of irregular heartbeats.I am not taking vitamin E supplements above the daily recommended dose.My tumor is still present or growing after diagnosis and I haven't had any treatment yet.My tumor can be measured and is at least 1 cm^2 in size.My tumor is a low-grade glioma or astrocytoma, but not a subependymal giant cell astrocytoma.My heart's pumping ability is normal or above normal.My child's blood pressure is within the normal range for their age, height, and gender.My blood pressure is controlled with medication.I can take care of myself but may not be able to do active work.I can swallow whole capsules.I have not had chemotherapy, radiation, immunotherapy, or a bone marrow transplant for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (vincristine sulfate, carboplatin)
- Group 2: Arm II (selumetinib sulfate)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 experiment only test on individuals below a certain age?
"This trial is open to anyone who falls in the 2-21 age bracket."
Answered by AI
How can I sign up for this opportunity to test a new treatment?
"Children aged 2-21 who have been diagnosed with astrocytoma are eligible for this clinical trial. Currently, the research team is looking to recruit approximately 220 patients."
Answered by AI
What are the harmful side effects of Selumetinib Sulfate?
"Selumetinib Sulfate is rated as a 3 in terms of safety by our team at Power. This is due to the fact that this drug has completed Phase 3 trials, thus there is some data supporting both efficacy and safety."
Answered by AI
In how many different settings is this research being conducted?
"100 patients are needed for this clinical trial, which is being conducted at Ascension Saint Vincent Indianapolis Hospital in Indianapolis, University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Cedars Sinai Medical Center in Los Angeles, and 100 other locations."
Answered by AI
Are there any patients presently enrolled in this clinical trial?
"Yes, according to the latest information on clinicaltrials.gov, this study is still recruiting patients. It was first posted on 1/3/2020, and the most recent update was on 11/8/2022. The trial needs 220 more participants across 100 locations."
Answered by AI
What are the most similar medical studies to Selumetinib Sulfate?
"Selumetinib sulfate was first studied in 2001 at the UCSF Helen Diller Family Comprehensive Cancer Center. Over 1500 studies have been completed thus far, with nearly 1000 more currently underway--a large number of which are based out of Indianapolis, Indiana."
Answered by AI
What illnesses does Selumetinib Sulfate help to alleviate?
"While often used to treat advanced sarcoma, selumetinib sulfate can also be given as initial treatment, or to patients with acquired immunodeficiency syndrome or advanced thymoma."
Answered by AI
How many people are involved in this clinical trial?
"The data on clinicaltrials.gov does indeed show that this study is recruiting participants at the moment. The trial was first posted on January 3rd, 2020 and was most recently updated on November 8th, 2022. Currently, the study is looking for 220 participants across 100 different locations."
Answered by AI
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