A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma (NCT04576117)

🧪 Interventions in This Study

• Selumetinib Sulfate (DRUG)
• Vinblastine Sulfate (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Feasibility phase: patients must be \>= 2 years and =\< 21 years of age at the time of enrollment
2. Efficacy phase: patients must be \>= 2 years and =\< 25 years of age at the time of enrollment
3. All patients \> 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age
4. Patients must have a body surface area (BSA) of \>= 0.5 m\^2 at enrollment
5. Patients must have eligibility confirmed by rapid central pathology and central molecular screening reviews performed on APEC14B1
6. Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
7. Patients must have progressive or recurrent LGG. Note: Biopsy may be at either initial diagnosis or recurrence
8. Patients must have measurable disease, defined as having a two-dimensional measurable tumor volume of \>= 1 cm\^2
9. Tumor size will be measured to include both solid and cystic components of the tumor (whether or not tumor is enhancing) + fluid attenuated inversion recovery (FLAIR) signal
10. Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization \[WHO\] grade 1 and II) by the WHO Classification of Tumors of the Central Nervous System - 4th Edition Revised, with the exception of subependymal giant cell astrocytoma
11. Patients with metastatic disease or multiple independent primary LGGs are eligible
12. Patients must be progressive or recurrent after having been treated with at least one prior tumor-directed therapy before enrollment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (101 Sites)

Showing the first 25 of 101 sites.

• Children's Hospital of Alabama — Birmingham, Alabama
• Arkansas Children's Hospital — Little Rock, Arkansas
• Loma Linda University Medical Center — Loma Linda, California
• Children's Hospital Los Angeles — Los Angeles, California
• Kaiser Permanente-Oakland — Oakland, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California
• Children's Hospital Colorado — Aurora, Colorado
• Connecticut Children's Medical Center — Hartford, Connecticut
• Yale University — New Haven, Connecticut
• Alfred I duPont Hospital for Children — Wilmington, Delaware
• Children's National Medical Center — Washington D.C., District of Columbia
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida
• UF Health Cancer Institute - Gainesville — Gainesville, Florida
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
• Arnold Palmer Hospital for Children — Orlando, Florida
• Nemours Children's Hospital — Orlando, Florida
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida
• Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia
• Saint Luke's Cancer Institute - Boise — Boise, Idaho
• Lurie Children's Hospital-Chicago — Chicago, Illinois
• University of Illinois — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Recurrent Low Grade Astrocytoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.