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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)
Must not have
Current or past history of retinal vein occlusion or retinal detachment
Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had issues with my retina, like detachment or vein blockage.
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I am not pregnant and have taken a pregnancy test if capable of becoming pregnant.
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I do not have uncontrolled glaucoma or eye pressure above 22 mmHg.
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I agree to use effective birth control during and for 12 weeks after the study.
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I have or had central serous retinopathy.
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I do not have any infections that are not under control.
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My MRI shows a tumor in a specific part of my brain stem, making me ineligible.
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I have not been treated for another cancer besides surgery in the past year.
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I have heart failure that causes me symptoms.
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I have heart issues that affect my daily activities.
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I have severe heart valve disease.
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I have a history of irregular heartbeats.
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I am not taking vitamin E supplements above the daily recommended dose.
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I have not had chemotherapy, radiation, immunotherapy, or a bone marrow transplant for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

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 more
Other 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 • NCT03040986
100%
Alanine aminotransferase increased
100%
Hypertension
100%
Aspartate aminotransferase increased
100%
Flatulence
100%
Pruritus
100%
Rash maculo-papular
50%
Hyperglycemia
50%
Hypercalcemia
50%
Hypoalbuminemia
50%
Gastroesophageal reflux disease
50%
Edema limbs
50%
Edema face
50%
Hypocalcemia
50%
Abdominal distension
50%
Dyspnea
50%
Platelet count decreased
50%
Neutrophil count decreased
50%
Paresthesia
50%
Fatigue
50%
Sore throat
50%
Muscle weakness trunk
100%
80%
60%
40%
20%
0%
Study treatment Arm
75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily
Dose Level 0: 75mg Selumetinib Sulfate Twice Daily

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
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Selumetinib Sulfate
2017
Completed Phase 2
~80

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Selumetinib, a MEK inhibitor, blocks enzymes essential for cell growth, leading to tumor cell death. Carboplatin, a chemotherapy agent, causes DNA damage that prevents cell division, while vincristine disrupts microtubule formation, inhibiting cell division. These mechanisms are vital for Low Grade Glioma patients as they target specific pathways involved in tumor growth, potentially improving treatment efficacy and quality of life.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,181 Total Patients Enrolled
Peter M de BlankPrincipal InvestigatorChildren's Oncology Group

Media Library

Carboplatin; Vincristine Sulfate (Alkylating Agent; Vinca Alkaloid) Clinical Trial Eligibility Overview. Trial Name: NCT04166409 — Phase 3
Low Grade Glioma Research Study Groups: Arm I (vincristine sulfate, carboplatin), Arm II (selumetinib sulfate)
Low Grade Glioma Clinical Trial 2023: Carboplatin; Vincristine Sulfate Highlights & Side Effects. Trial Name: NCT04166409 — Phase 3
Carboplatin; Vincristine Sulfate (Alkylating Agent; Vinca Alkaloid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166409 — Phase 3
~77 spots leftby Dec 2026