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Protocol No. ACNS1721

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

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 BRAF

Objective The study doctors want to see if using veliparib with radiation therapy followed by veliparib with temozolomide during maintenance therapy will be better than treatment with temozolomide alone in helping to get rid of or shrink HGGs. 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. The combination of veliparib with radiation therapy and veliparib with temozolomide is experimental

Treatment Surgery to remove tumor: Pre-Screening on APEC14B1: Confirmed high-grade glioma without H3 K27M or BRAFV600E mutations: Enrollment on ACNS1721: Chemoradiotherapy: Radiation Therapy + Veliparib(6-7 weeks) followed by Rest period(4 weeks): Followed by: Maintenance Chemotherapy: Veliparib + Temozolomide (up to 10 cycles)

Description Phase 2 Veliparib Radiation Treatment and Temo for Newly Diagnosed Malignant Glioma without H2 K27M or BRAFV600

Key Eligibility
Age
  • Stratum 1 (IDH wild-type): Patients must be greater than or equal to 3 years of age and less than or equal to 21 years of age at the time of enrollment
  • Stratum 2 (IDH mutant): Patients must be greater than or equal to 3 years of age and less than or equal to 25 years of age at the time of enrollment
    Diagnosis
  • Patients must have eligibility confirmed by rapid central pathology and central molecular screening reviews performed on APEC14B1
  • Newly-diagnosed high-grade glioma such as anaplastic astrocytoma or glioblastoma
  • Negative results for H3 K27M by immunohistochemistry (IHC)
  • Negative results for BRAFV600E mutation by Next-Generation Sequencing (NGS) Patients must have histological verification of diagnosis. Patients with M+ disease (defined as evidence of neuraxis dissemination) are not eligible. CSF cytology is not required but may be obtained if clinically indicated prior to study enrollment. If cytology is positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible
  • Pre-operative and post-operative brain MRI with and without contrast must be obtained. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. A spine MRI is not required, but may be obtained if clinically indicated. If the spine MRI is positive, the patient would be considered to have M+ disease (defined as neuraxis dissemination) and would be ineligible
  • Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients greater than 16 years of age and Lansky for patients less than or equal to 16 years of age
  • Adequate Bone Marrow, Renal, Liver and Central Nervous system Function as described by the protocol
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive diagnostic surgery
    EXCLUSION:
  • Patients with the following histologies: - Diffuse astrocytoma (Grade 2), Oligodendrogliomas (any grade), Pleomorphic xanthoastrocytoma (PXA, any grade)
  • Patients with primary tumor location of brainstem or spinal cord
  • Patients with M+ disease (defined as neuraxis dissemination either by imaging or by cytology)
  • Patients with treatment-related AML (t-AML)/MDS or with features suggestive of AML/MDS
  • Prior allogenic bone marrow transplant or double umbilical cord blood transplantation Prior Therapy: Patients must not have received any prior tumor-directed therapy including radiation therapy, chemotherapy (tumor-directed therapy), molecularly targeted agents, or immunotherapy for the treatment of HGG other than surgical intervention and/or corticosteroids Patients with gliomatosis cerebri type 1 or 2. Patients with known constitutional mismatch repair deficiency syndrome (CMMR-D)/biallelic mismatch repair deficiency (bMMRD)
  • Patients who are not able to receive protocol specified radiation therapy
  • Female patients who are pregnant or breast feeding, or positive pregnancy test
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method as described by the protocol

  • Applicable Disease Sites Brain/Central Nervous System

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics