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COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Recruiting

The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).

I'm interested

Male or Female
Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 21 years old
• all tumors considered low-grade glioma or low-grade astrocytoma
• patients with metastatic disease or multiple independent primary LGG are eligible
• patients must have the ability to swallow whole capsules
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted

Procedure: Biospecimen Collection, Drug: Carboplatin, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Selumetinib Sulfate, Drug: Vincristine Sulfate

Cancer

Brain Cancer, Low Grade Astrocytoma, Low Grade Glioma

Allison Fullenkamp - fulle631@umn.edu
Christopher Moertel, MD
PHASE3
SITE00000799
See this study on ClinicalTrials.gov

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