Selumetinib vs Carboplatin and Vincristine for Low-Grade Glioma

A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma

Recruiting Phase 3 Interventional Study
Low Grade Astrocytoma Low Grade Glioma Metastatic Low Grade Astrocytoma Metastatic Low Grade Glioma WHO Grade 1 Glioma WHO Grade 2 Glioma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 21
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for patients aged 2 to 21 who have low-grade glioma and have not been treated before. Participants will compare a new drug, selumetinib, with standard chemotherapy treatments.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 2 and 21 years old.
  • I have low-grade glioma without a BRAFV600E mutation.
  • I have measurable tumor size of 1 cm² or larger.
  • I have not received previous treatments except for surgery.
  • I am not currently on any medications that interfere with the study.
  • I can swallow whole capsules.
  • I have signed an informed consent form.

You may not be able to join if

  • I have received tumor-directed therapy like chemotherapy or radiation before.
  • I have a serious medical or psychiatric condition that affects my treatment.
  • I am pregnant.
  • I have another serious cancer besides low-grade glioma.
  • I have been diagnosed with a specific type of brain tumor that affects my eligibility.
  • I cannot comply with the study procedures.
  • I am currently taking investigational drugs or treatments.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must be \>= 2 years and =\< 21 years at the time of enrollment * Patients must have a body surface area (BSA) of \>= 0.5 m\^2 at enrollment * Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by …
Contacts

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