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MEK Inhibitor
Selumetinib + Vinblastine for Low-Grade Glioma
Phase 3
Recruiting
Led By Daniel C Bowers
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is investigating whether adding vinblastine to selumetinib improves treatment of recurrent or progressive low-grade glioma in children and young adults.
Who is the study for?
This trial is for children and young adults aged 2-21 (up to 25 in some phases) with low-grade glioma that's recurrent or progressive after treatment. Participants must have had prior therapy, a body surface area of at least 0.5 m^2, stable organ function, no severe allergies to the drugs being tested, controlled blood pressure, and the ability to swallow capsules.
What is being tested?
The study compares two treatments: Selumetinib alone versus a combination of Selumetinib and Vinblastine. It aims to find out if adding Vinblastine improves outcomes for patients with low-grade glioma that has returned or isn't responding well to other treatments.
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from Vinblastine; skin rash, eye problems like blurred vision from Selumetinib; as well as potential liver issues and high blood pressure which could be caused by either drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free survival (efficacy)
Vinblastine
Secondary study objectives
EFS by BRAF Status
Incidence of adverse events (efficacy)
Incidence of adverse events (feasibility)
+4 moreSide effects data
From 2020 Phase 2 trial • 8 Patients • NCT03040986100%
Aspartate aminotransferase increased
83%
Edema limbs
83%
Hypoalbuminemia
67%
Fatigue
67%
Hypertension
50%
Abdominal pain
50%
Anemia
50%
Dyspnea
50%
Alkaline phosphatase increased
50%
Anorexia
50%
Alanine aminotransferase increased
50%
Nausea
33%
Dizziness
33%
Hypocalcemia
33%
Generalized muscle weakness
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%
Heart failure
17%
Pancreatitis
17%
Diarrhea
17%
Dry mouth
17%
Colonic obstruction
17%
Confusion
17%
Gallbladder obstruction
17%
Gallbladder infection
17%
Lipase increased
17%
Serum amylase increased
17%
Ascites
17%
Dysgeusia
17%
Alopecia
17%
Edema trunk
17%
White blood cell decreased
17%
Atelectasis
17%
Dysphagia
17%
Glucose intolerance
17%
Hyperglycemia
17%
Weight loss
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
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)Experimental Treatment6 Interventions
Patients receive vinblastine sulfate IV over 1 minute or IV infusion on days 1, 8, 15, and 22 and selumetinib sulfate PO BID on days 1-28. Treatment repeats every 28 days. Patients receive selumetinib and vinblastine for a total duration of 17 cycles followed by 10 additional cycles of selumetinib alone in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
Group II: Efficacy Phase Arm II (selumetinib)Active Control5 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 undergo MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Selumetinib Sulfate
2017
Completed Phase 2
~80
Biospecimen Collection
2004
Completed Phase 3
~2020
Vinblastine Sulfate
2007
Completed Phase 4
~300
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,890 Previous Clinical Trials
41,011,691 Total Patients Enrolled
141 Trials studying Astrocytoma
13,318 Patients Enrolled for Astrocytoma
Daniel C BowersPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be between 2 and 21 years old to participate in the study's feasibility phase.You are allergic to selumetinib, vinblastine, or similar drugs.You have existing eye problems.You have glaucoma that is not being managed or controlled.You have had treatment for any other type of cancer within the last year, besides surgery.You cannot have stopped taking vinblastine or selumetinib because of negative side effects.You must be able to swallow capsules without crushing or breaking them.You have a tumor that can be measured and its size is at least 1 square centimeter.If you have a history of seizures, you should not have had more seizures than usual in the 2 weeks leading up to the study.You have a heart condition before participating in the trial.You have symptoms of heart failure.You have a serious problem with one of your heart valves.You cannot be taking any other experimental drugs.You have a past record of irregular heartbeat called atrial fibrillation.You are a breastfeeding mother who plans to continue breastfeeding during the study.You currently have an infection that is not under control.You can participate in the trial if you have either cancer that has spread to other parts of the body or multiple brain tumors that are not related to each other.You must have a certain body size, with a surface area of at least 0.5 square meters.You must be between 2 and 25 years old when you join the study.The size of the tumor will be measured, including both solid and fluid-filled parts, as well as a specific type of MRI signal.The type of brain tumor you have is considered low-grade (not very aggressive) according to the World Health Organization's classification system. However, if you have a type called subependymal giant cell astrocytoma, you won't be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Efficacy Phase Arm II (selumetinib)
- Group 2: Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)
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.
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