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)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Newly Diagnosed Or Previously Untreated Low-grade Glioma (lgg) Not Associated With Brafv600e Mutations Or Systemic Neurofibromatosis Type 1 (nf1)
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Age: Between 2 Year(s) - 21 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
1. Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation. 2. Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible 3) Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
You may not be eligible for this study if the following are true:
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1) Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted 2) Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible 3) Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.