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

Conditions

• Recurrent Low Grade Astrocytoma
• Recurrent WHO Grade 2 Glioma
• Refractory Low Grade Astrocytoma
• Refractory Low Grade Glioma
• Refractory WHO Grade 1 Glioma

Eligibility Criteria

Sex

ALL

Age

2 Years - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Selumetinib Sulfate — DRUG
  Given PO
• Vinblastine Sulfate — DRUG
  Given IV

Study Details

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Key Dates

Start date

Feb 16, 2021

Status verified

Feb 2026

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Efficacy Phase Arm II (selumetinib)
  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.
• Experimental: Feasibility & Efficacy Phase Arm I (selumetinib, vinblastine)
  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.

Primary Outcome Measure

Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of selumetinib and vinblastine combination (feasibility) [ Time Frame: 1 month post enrollment ]

Locations (91)

Find similar trials in Birmingham, AL

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