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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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 (efficacy)
Vinblastine
Secondary outcome measures
EFS by BRAF Status
Incidence of adverse events (efficacy)
Incidence of adverse events (feasibility)
+4 more

Side effects data

From 2020 Phase 2 trial • 8 Patients • NCT03040986
100%
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: 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
~1190
Selumetinib Sulfate
2017
Completed Phase 2
~80
Biospecimen Collection
2004
Completed Phase 2
~1700
Vinblastine Sulfate
2007
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,554 Total Patients Enrolled
140 Trials studying Astrocytoma
13,302 Patients Enrolled for Astrocytoma
Daniel C BowersPrincipal InvestigatorChildren's Oncology Group

Media Library

Selumetinib Sulfate (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04576117 — Phase 3
Astrocytoma Research Study Groups: Efficacy Phase Arm II (selumetinib), Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)
Astrocytoma Clinical Trial 2023: Selumetinib Sulfate Highlights & Side Effects. Trial Name: NCT04576117 — Phase 3
Selumetinib Sulfate (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576117 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary indication for Selumetinib Sulfate?

"Selumetinib Sulfate is an effective treatment for advanced testicular cancer, lymphoma, hodgkins disease, and breast cancer."

Answered by AI

Is this clinical trial being run in numerous locations throughout the state?

"There are 67 sites running this trial, including Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center in Houston, University of Illinois in Chicago, Cardinal Glennon Children's Medical Center in Saint Louis, and other locations."

Answered by AI

Who would be an ideal candidate for this clinical test?

"Researchers are looking for 300 individuals, falling in the 2-25 year old age bracket, that have glioma. In addition to this broad criteria, patients must also meet the following more specific requirements: Efficacy phase: at enrollment, patients must be between 2 and 25 years old, must have a body surface area of at least 0.5 m^2 , have a two-dimensional measurable tumor volume of 1 cm^2 or greater, with tumor size including both solid and cystic components of the tumor (whether or not tumor is enhancing) + fluid attenuated inversion recovery (FLAIR) signal. Eligible hist"

Answered by AI

Are there comparable clinical trials that have used Selumetinib Sulfate?

"Selumetinib Sulfate was first studied in the year 2002 at Canberra Hospital. So far there have been 475 completed trials. There are currently 138 actively recruiting trials, with many of these trials being performed out of Houston, Texas."

Answered by AI

How many test subjects are in this experiment?

"Yes, the clinical trial is still recruiting patients. The details were last updated on November 9th, 2022 and it was originally posted on January 8th, 2021. They are looking for 300 total patients from 67 different hospitals or clinics."

Answered by AI

Can young adults participate in this research?

"To be eligible for this particular trial, applicants must fall between the ages of 2 and 25. Out of all the ongoing trials, 331 are for patients below 18 years old while 1244 are for senior citizens aged 65 and above."

Answered by AI

Are we still recruiting patients for this research project?

"That is correct. The latest information on clinicaltrials.gov shows that this trial is still looking for patients. It was first posted over a year ago on 8/1/2021 and was most recently updated on 9/11/2022. There are 67 hospitals or clinics participating in the study, and they are hoping to enroll 300 people total."

Answered by AI

What is the current FDA status of Selumetinib Sulfate?

"Selumetinib Sulfate Phase 3 trials have yielded some efficacy data, and there are numerous rounds of safety data, so it receives a score of 3."

Answered by AI

What hypotheses is this research trying to confirm?

"The primary goal of this clinical trial is to Event-free survival (efficacy), which will be measured over a 1 month post enrollment time frame. Secondary outcomes include Radiographic tumor response rate (efficacy) and Visual outcome comparison, which will be assessed using an exact binomial test to compare the difference in the proportion of subjects in each arm that show improvement in visual acuity per Teller Acuity assessment after 12 months of treatment. Additionally, EFS by BRAF Status will be estimated using KM methods to estimate the difference in EFS and between patients with BRAF rearranged LGG and patients with non-B"

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Other
California
British Columbia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Kaiser Permanente-Oakland
~137 spots leftby Dec 2026