A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
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Clinical Trial Information
Trial Contact: Dubberly, Paige D; Parker, Melanie; Doyle, Katherine M; Armatti, Julie M; Frankos, Marie
Trial Phone: 321-841-7561 ; 321-843-1036 ; 3218412008 ; 321-843-5284 ; 321-842-8738
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IRB No: ACNS1931
Protocol Abbrev: ACNS1931
Principal Investigator:
Phase: Drug: Phase III
Age Group: Adult; Pediatric
Secondary Protocol No: ACNS1931
Treatment: Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Selumetinib Sulfate, Drug: Vinblastine Sulfate
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04576117
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Objective
I. To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib sulfate (selumetinib) + vinblastine sulfate (vinblastine) for children with progressive or recurrent low-grade gliomas (LGGs).
II. To determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs. -
Key Eligibility
- Patients must be ≥ 2 years and ≤ 25 years of age at the time of enrollment on Step 0.
- 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.
- Patient is suspected of having progressive or recurrent low-grade glioma (LGG).
- Patient does not have a known diagnosis of neurofibromatosis type 1 (NF1) or tuberous sclerosis complex (TSC).
