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ACNS1721: Phase 2 Trial of Veliparib, Radiation Therapy, and Temozolomide for Newly Diagnosed High-Grade Glioma

About this study

A glioma is a type of cancer that grows as a tumor in the brain. A glioma is considered “high grade” when it is growing and spreading quickly.

High-grade gliomas (HGGs) are hard to treat successfully. Standard treatment includes surgery to remove as much tumor as possible followed by radiation therapy (treatment with high-energy x-rays or high-energy protons) to kill cancer cells or keep them from growing. Other commonly used treatments may include chemotherapy (anti-cancer drugs) given during and after radiation treatment. Temozolomide is one of the chemotherapy drugs that may be used during and after radiation therapy to treat newly-diagnosed HGG. Maintenance therapy is therapy given after radiation therapy.

In this study, doctors want to find treatments that will be better at getting rid of or shrinking HGGs and stopping them from coming back. One thing they want to do is try using different chemotherapy drugs during radiation therapy.

If you are eligible for this study, you will receive a drug called veliparib. Veliparib is a drug that works differently than regular chemotherapy drugs. It kills cancer cells by blocking a protein that repairs DNA or genetic damage in cancer cells. In this study, veliparib will be given with radiation therapy and with temozolomide. This combination is considered experimental.

You may or may not benefit from the treatment you receive in this study. However, the information learned from the study may benefit other patients in the future.

Eligibility overview

  • 3 to 25 years old
  • Newly diagnosed high-grade glioma, such as anaplastic astrocytoma or glioblastoma
  • Negative test for H3 K27M mutation
  • Negative test for BRAFV600 mutation

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

A Phase II Study of Veliparib (ABT-888, IND# 139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations

Study goal:

The main goal of this study is to find out if veliparib given with radiation therapy, followed by veliparib with temozolomide, works better than treatments that have been tried in the past. Researchers also want to find out what good and bad effects this treatment has on patients with newly diagnosed high-grade glioma.

Diagnosis:

High-grade glioma

Age:

3 to 25 years old

Clinical trials categories:

Childhood Cancer High-Grade Glioma Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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