Study Comparing Selumetinib with Carboplatin and Vincristine for Low-Grade Glioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04166409

Provider View

This clinical trial is comparing the effects of the drug selumetinib with the standard chemotherapy treatment of carboplatin and vincristine in patients with low-grade glioma, a type of brain tumor. The study aims to see if selumetinib is as effective as the standard treatment and if it improves patients' quality of life.

Patient Parameters

Program Overview

This study is testing whether the drug selumetinib can work as well as the standard chemotherapy treatment of carboplatin and vincristine for patients with low-grade glioma (LGG), a type of brain tumor. The trial is for patients who do not have a specific genetic mutation (BRAFV600E) and are not affected by a condition called neurofibromatosis type 1. Selumetinib may help by blocking enzymes needed for tumor growth, while carboplatin and vincristine work by stopping tumor cells from growing or dividing. The study will also look at whether selumetinib can improve the quality of life for patients.

Description

The main goal of this study is to see if selumetinib is as effective as the standard chemotherapy treatment of carboplatin and vincristine in helping patients with low-grade glioma live longer without the cancer getting worse. The study will also look at how well each treatment works in shrinking tumors and improving vision and motor skills in children with these tumors. Additionally, the study will evaluate the quality of life and cognitive, social, emotional, and behavioral functioning of children receiving either treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1 (Standard Treatment): Patients will receive vincristine and carboplatin through an IV. This treatment will be given in cycles, with breaks in between, for up to 8 cycles. Blood samples and MRI scans will be taken throughout the study.

  • Group 2 (Selumetinib): Patients will take selumetinib pills twice a day. This treatment will be given in cycles, with breaks in between, for up to 27 cycles. Blood samples and MRI scans will be taken throughout the study.

After finishing the treatment, patients will have follow-up visits every few months to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Age between 2 and 21 years old.
  • Body surface area of at least 0.5 m².
  • Diagnosed with low-grade glioma without the BRAFV600E mutation and not related to neurofibromatosis type 1.
  • Tumor must be measurable and at least 1 cm² in size.
  • Good kidney function and normal blood test results.
  • Able to swallow pills.
  • Must have had an eye exam and MRI scan before starting the study.
  • Must be able to understand and agree to the study requirements.
  • Must not have received any prior treatment for the tumor other than surgery.
  • Must have a performance status that allows for normal daily activities.
  • Must agree to use effective birth control during the study and for 12 weeks after.

Exclusion Criteria

  • Have received any prior treatment for the tumor other than surgery.
  • Have another type of cancer or have been treated for another tumor in the past year.
  • Have certain types of brain tumors or other serious medical conditions.
  • Are pregnant or breastfeeding.
  • Are unable to comply with the study requirements.
  • Have a history of heart problems or certain eye conditions.
  • Are taking vitamin E supplements above the recommended daily dose.
  • Have had recent surgery, except for specific minor procedures.
  • Have an uncontrolled infection.

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