Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:December 15, 2014

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A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

This randomized phase II/III trial studies how well temozolomide and veliparib work compared
to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme.
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. Veliparib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. It is not yet known whether temozolomide is more effective
with or without veliparib in treating glioblastoma multiforme.

PRIMARY OBJECTIVES:

I. Test whether the experimental combination of ABT-888 (veliparib) combined with TMZ
(temozolomide), compared to the control of placebo combined with TMZ, significantly extends
overall survival in newly diagnosed glioblastoma multiforme (GBM) patients with tumor MGMT
promoter hypermethylation.

SECONDARY OBJECTIVES:

I. Test whether the experimental treatment significantly extends progression-free survival.

II. Test whether the experimental treatment improves objective tumor response. III. Test
whether the experimental treatment is associated with significantly greater rates of grade 3
or higher adverse events.

TERTIARY OBJECTIVES:

I. Evaluate the utility of dynamic susceptibility contrast (DSC) and diffusion weighted
imaging (DWI) magnetic resonance imaging (MRI) techniques in defining time to progression in
the setting of a large multi-institutional clinical trial.

II. Test the concordance between site-determined MGMT methylation status and central
laboratory determination of MGMT status in cases with local testing.

III. Evaluate whether genetic or epigenetic alterations in deoxyribonucleic acid (DNA) repair
or replication genes are associated with overall survival, progression-free survival, and
objective tumor response.

IV. Test whether polymorphisms in MGMT, PARP1, or other DNA repair proteins, are associated
with overall survival, progression-free survival, objective tumor response, or rates of grade
3 or higher adverse events.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and veliparib PO
twice daily (BID) on days 1-7. Treatment repeats every 28 days for 6 courses in the absence
of disease progression (confirmed progression) or unacceptable toxicity.

ARM II: Patients receive temozolomide as in Arm I and placebo PO BID on days 1-7. Treatment
repeats every 28 days for 6 courses in the absence of disease progression (confirmed
progression) or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years,
every 6 months for 2 years.

Inclusion Criteria:

- Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV
intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT
PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with
oligodendroglial features will be asked to provide results of 1p/19q codeletion status

- Sufficient tissue available for central pathology review and MGMT methylation status
evaluation

- Patients who have had a local MGMT testing that is unmethylated are not allowed to
participate

- Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson

- Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma

- Absolute neutrophil count (ANC) >= 1500 cells/mm^3 (within 14 days prior to study
registration)

- Platelets >= 100,000 cells/mm^3 (within 14 days prior to study registration)

- Creatinine =< 1.5 x upper limit of normal (ULN) (within 14 days prior to study
registration)

- Bilirubin =< 1.5 x ULN (within 14 days prior to study registration; unless patient has
Gilbert's disease)

- Alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to study registration)

- Aspartate aminotransferase (AST) =< 3 x ULN (within 14 days prior to study
registration)

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Measurable disease or non-measurable disease; extent of resection: patients with
complete resection, partial resection, or biopsy are eligible

- Progression: patients deemed to have progressive disease based on clinical
deterioration after chemoradiation or radiographic progression outside of the
radiation field are not eligible; patients deemed to have pseudoprogression are
eligible

- Prior treatment:

- Must have completed standard radiotherapy and concomitant TMZ therapy as defined
and determined by the study oncologist

- Besides concomitant TMZ with radiation, no other therapy (neo-adjuvant or
adjuvant) can be given prior to study registration, including chemotherapy (also
including Gliadel/carmustine [BCNU] wafers), biologics, immunotherapy, radiation
therapy; the only exception is the Optune device (NovoTTF-100A), which may be
started any time after end of radiation therapy up through the initiation of
Cycle 1; intent to use Optune must be declared at registration for stratification

- No prior allogeneic bone marrow transplant or double umbilical cord blood
transplantation

- Not pregnant and not nursing; females of childbearing potential must have negative
urine or serum pregnancy test within 7 days of registration but before start of
treatment; a female of childbearing potential is a sexually mature female who:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months)

- Concomitant medications: patients receiving anticoagulation should be on stable dose 2
weeks prior to registration

- Comorbid conditions: patients are unable to participate due to the following:

- Generalized or partial seizure disorder that is uncontrolled at the time of
registration; the definition of controlled generalized seizures is patients must
be on a stable dose of anti-seizure medication and without generalized seizures
for at least 10 days prior to registration; the definition of controlled partial
seizures is patients must be on a stable dose of anti-seizure medication for at
least 10 days prior to registration; patients with occasional breakthrough
partial seizures are allowed at treating physician's discretion

- Grade 3 or 4 thromboembolic disease within 6 months (mo) of registration

- Known history of prolonged QT syndrome

- No history of major surgery =< 14 days prior to registration

- Patients must have adequate organ and marrow function measured within 28 days prior to
administration of ABT-888 as defined below:

- >= 10.0 g/dL hemoglobin (Hb) with no blood transfusion in the past 28 days

- No Patients with treatment-related acute myeloid leukemia (AML)
(t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS
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Principal Investigator: Na Tosha N. Gatson
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Danville, Virginia 24541
Principal Investigator: Qiwei W. Gai
Phone: 434-799-3753
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Danville, VA
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, OH
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Dayton, OH
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Dayton, Ohio 45415
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Dayton, OH
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Dayton, OH
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Decatur, IL
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210 West McKinley Avenue
Decatur, Illinois 62526
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Decatur, IL
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Deerfield Beach, Florida 33442
Principal Investigator: Macarena I. De La Fuente
Phone: 305-243-2647
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Deerfield Beach, FL
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Denver, Colorado 80205
Principal Investigator: Alexander Menter
Phone: 303-777-2663
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Denver, CO
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, IA
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Principal Investigator: Robert J. Behrens
Phone: 515-239-2621
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Des Moines, IA
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Des Moines, Iowa 50314
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
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Des Moines, IA
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Detroit, Michigan 48236
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Detroit, MI
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Dodge City, KS
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Duluth, Minnesota 55805
Principal Investigator: Homam Alkaied
Phone: 773-702-9171
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Duluth, MN
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