A Phase II Study of Veliparib plus Radiation Therapy in Patients with Newly Diagnosed High-Grade Glioma

Full Title

A Phase 2 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 (ACNS1721) (CIRB)

Purpose

High-grade gliomas (HGGs) are brain tumors that are challenging to treat successfully. Doctors are seeking treatments that will be more effective for eliminating or shrinking HGGs and stopping them from coming back. One approach is to use different chemotherapy drugs during radiation therapy (chemoradiotherapy). In this study, researchers are evaluating the use of veliparib combined with chemotherapy in children, adolescents, and young adults newly diagnosed with HGG.

Patients must not have genetic mutations called H3 K27M or BRAF V600E in their cancer cells. This is important because patients without these genetic changes have been shown to most likely benefit from veliparib treatment. Veliparib works by blocking a protein that repairs DNA damage in cancer cells.

In this study, patients will receive veliparib and radiation therapy followed by veliparib with temozolomide as maintenance therapy. Temozolomide is already used to treat glioma. Both veliparib and temozolomide are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be at least 3 and no older than 25 years of age.
  • Patients must have newly diagnosed high-grade glioma that has not yet been treated (except for surgery).
  • Patients tumors may not contain the H3 K27M or BRAF V600E mutations.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Matthias Karajannis at 212-639-3171.

Protocol

18-521

Phase

II

Disease Status

Newly Diagnosed

Investigator