Veliparib, Radiation Therapy, and Temozolomide in Treating Participants With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600E Mutations



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 25
Updated:4/6/2019
Start Date:October 31, 2018
End Date:October 29, 2024

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A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600E Mutations

This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in
treating participants with newly diagnosed malignant glioma without H3 K27M or BRAFV600E
mutations. Veliparib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. 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 participants with newly diagnosed malignant glioma without H3 K27M or
BRAFV600E mutations.

PRIMARY OBJECTIVES:

I. To determine whether veliparib (ABT-888), when added to radiotherapy (RT) and
temozolomide, is efficacious for the treatment of patients with newly-diagnosed high-grade
glioma (HGG) whose tumors' molecular profile are wild-type for H3 K27M, BRAFV600E, and
IDH1/2.

II. To determine whether veliparib (ABT-888), when added to RT and temozolomide, is
efficacious for the treatment of patients with newly-diagnosed HGG whose tumors' molecular
profile are wild-type for H3 K27M and BRAFV600E and harbor an IDH1/2 mutation.

SECONDARY OBJECTIVES:

I. To explore associations of genomic, transcriptomic, and/or epigenetic alterations of the
tumors with treatment response and outcome.

II. To explore the extent to which patients with BRCA1/2 gene alterations and other
deoxyribonucleic acid (DNA) damaged genes display tumor genomic features consistent with
homologous repair deficiency (HRD), including large scale state transitions (LSTs),
mutational signature 3, and an enrichment for deletions flanked by sequences of (micro)
homology.

III. To explore the burden of high, moderate, and low penetrant germline alterations in HRD
genes (such as BRCA1, BRCA2, PALB2, Fanconi complex genes, ATM, CHEK2, RAD51B/C/D), mis-match
repair genes (such as MLH1, MSH2, MSH6, PMS2, EPCAM), and energy metabolism genes (such as
SDHA, SDHB, SDHC, SDHAF2, SDHD, IDH1, IDH2, and FH).

IV. To explore constitutional imprinting abnormalities associated with EP300 and IGF2 in
peripheral blood from patients with HGGs.

OUTLINE:

CHEMORADIOTHERAPY PHASE: Participants receive veliparib orally (PO) twice daily (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, participants
receive veliparib PO BID and temozolomide PO once daily (QD) on days 1-5. Treatment repeats
every 28 days for up to 10 courses in the absence of disease progression or unacceptable
toxicity.

Inclusion Criteria:

- Stratum 1 (IDH wild-type): Patients must be >= 3 years of age and =< 21 years of age
at the time of enrollment

- Stratum 2 (IDH mutant): Patients must be >= 3 years of age and =< 25 years of age at
the time of enrollment

- 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. Cerebrospinal fluid
(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 magnetic resonance imaging (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 of >= 50 by Lansky or Karnofsky, corresponding
to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for
patients > 16 years of age and Lansky for patients =< 16 years of age. Patients who
are unable to walk because of paralysis, but are up in a wheelchair will be considered
ambulatory for the purposes of assessing the performance score

- Peripheral absolute neutrophil count (ANC) >= 1,000/uL

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 8.0 gm/dL (can be transfused)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:

- 3 to < 6 years: 0.8 (male and female) maximum serum creatinine (mg/dL)

- 6 to < 10 years: 1 (male and female) maximum serum creatinine (mg/dL)

- 10 to < 13 years: 1.2 (male and female) maximum serum creatinine (mg/dL)

- 13 to < 16 years: 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)

- >= 16 years: 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age

- Patients with seizure disorder may be enrolled if seizures are well-controlled (i.e.,
patients must not have required rescue medications for uncontrolled seizures within 14
days prior to enrollment)

- Patients must be enrolled and protocol therapy must be projected to begin no later
than 31 days after definitive diagnostic surgery (Day 0)

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- 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 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

- Lumbar CSF cytology is not required, but may be performed if clinically indicated
prior to study enrollment. If lumbar CSF cytology is positive, the patient is
considered to have M+ disease and is ineligible

- Note: False positive cytology can occur within 10 days of surgery

- Patients with gliomatosis cerebri type 1 or 2

- Patients who are not able to receive protocol specified radiation therapy

- Patients must not be currently receiving other anti-cancer agents

- Patients with known constitutional mismatch repair deficiency syndrome
(CMMR-D)/biallelic mismatch repair deficiency (bMMRD)

- Female patients who are pregnant are ineligible due to risks of fetal and teratogenic
adverse events as seen in animal/human studies

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation and for 4 months after the last dose of veliparib
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Salt Lake City, Utah 84143
Principal Investigator: Phillip E. Barnette
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Salt Lake City, UT
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San Antonio, Texas 78207
Principal Investigator: Timothy C. Griffin
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San Antonio, TX
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Principal Investigator: Andrew L. Pendleton
Phone: 912-350-7887
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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Savannah, GA
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Douglas S. Hawkins
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
Principal Investigator: Kayelyn J. Wagner
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls Sanford
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Sioux Falls, SD
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Principal Investigator: Judy L. Felgenhauer
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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Spokane, WA
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Syracuse, New York 13214
Principal Investigator: Philip M. Monteleone
Phone: 315-464-5476
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Syracuse, NY
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311 Martin Luther King Jr Way
Tacoma, Washington 98403
(253) 403-1400
Principal Investigator: Robert G. Irwin
Mary Bridge Children's Hospital and Health Center Mary Bridge Children's Hospital was established in 1955,...
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Tacoma, WA
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
Principal Investigator: Jamie L. Dargart
Phone: 419-824-1842
The Toledo Hospital/Toledo Children's Hospital ProMedica's Mission is to improve your health and well-being. And...
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Toledo, OH
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901 45th St
West Palm Beach, Florida 33407
(561) 844-6300
Principal Investigator: Narayana Gowda
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
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West Palm Beach, FL
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Christopher P. Keuker
Phone: 508-856-3216
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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Worcester, MA
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