Purpose

This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.

Category

IRB Number
20180791HU
NCT Number
NCT03581292
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
210-562-9149
diazvr@uthscsa.edu

Jaclyn Hung
210-450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between 3 Years and 25 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Anaplastic Astrocytoma
    2. Glioblastoma
    3. Malignant Glioma

      4. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (veliparib, radiation therapy, temozolomide)

      		CHEMORADIOTHERAPY PHASE: Patients receive veliparib PO BID and undergo 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after chemoradiotherapy phase, patients receive veliparib PO BID and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
    4. Drug: Temozolomide

      Given PO

      Other names:

      • CCRG-81045
      • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
      • M & B 39831
      • M and B 39831
      • Methazolastone
      • RP-46161
      • SCH 52365
      • Temcad
      • T

    5. Radiation: Radiation Therapy

      Undergo radiation therapy

      Other names:

      • Cancer Radiotherapy
      • ENERGY_TYPE
      • Irradiate
      • Irradiated
      • Irradiation
      • Radiation
      • Radiation Therapy, NOS
      • Radiotherapeutics
      • Radiotherapy
      • RT
      • Therapy, Radia

    6. Drug: Veliparib

      Given PO

      Other names:

      • ABT-888
      • PARP-1 inhibitor ABT-888

      7.