ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT ID: NCT00770471
Last Updated: 2018-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2009-07-13
2012-03-01
Brief Summary
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PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when given together with radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.
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Detailed Description
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Primary
* To determine the maximum tolerated dose (MTD) of ABT-888 when administered in combination with radiotherapy and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I)
* To estimate the overall survival of patients treated with ABT-888 when administered at the MTD in combination with radiotherapy and temozolomide. (Phase II)
Secondary
* To assess the toxicity associated with this regimen. (Phase I)
* To assess and describe the pharmacokinetics of ABT-888. (Phase I)
* To estimate the frequency of toxicity associated with this regimen. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of ABT-888 followed by a phase II study.
* Initiation therapy: Patients receive oral ABT-888 twice daily (once on day 1 only) and oral temozolomide once daily (beginning on day 2) in weeks 1-6. Patients enrolled in the phase I dose-escalation/phase II portion of the study also undergo concurrent radiotherapy once daily 5 days a week (beginning on day 2) in weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity.
* Maintenance therapy: Beginning 4 weeks after completion of initiation therapy, patients receive oral ABT-888 twice daily on days 1-7 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 4 courses (6 courses for patients enrolled in the phase I dose-escalation/phase II portion of the study) in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic, pharmacogenetic, and pharmacodynamic analysis. Samples are analyzed for concentration of ABT-888 in plasma by reversed-phase isocratic high performance liquid chromatography with electrospray ionization mass spectrometry; identification of novel markers of treatment response by plasma proteomic evaluation; DNA methylation and/or mutation; and PARP inhibition by ELISA.
After completion of study therapy, patients are followed every 2 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
temozolomide
veliparib
DNA methylation analysis
gene expression analysis
mutation analysis
proteomic profiling
high performance liquid chromatography
immunoenzyme technique
laboratory biomarker analysis
mass spectrometry
pharmacogenomic studies
pharmacological study
adjuvant therapy
radiation therapy
Interventions
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temozolomide
veliparib
DNA methylation analysis
gene expression analysis
mutation analysis
proteomic profiling
high performance liquid chromatography
immunoenzyme technique
laboratory biomarker analysis
mass spectrometry
pharmacogenomic studies
pharmacological study
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
* Newly diagnosed disease
* Patients enrolled in the phase I initial safety portion of the study must meet the following additional criteria:
* Received 90% of planned radiotherapy and ≥ 80% of planned concurrent temozolomide within the past 28-49 days
* No grade 3-4 toxicity attributed to temozolomide
* Has undergone gadolinium MRI or contrast CT scan within the past 28 days
* Patients enrolled in the phase I dose-escalation/phase II portion of the study must meet the following additional criteria:
* Recovered from immediate post-operative period and maintained on a stable corticosteroid regimen (no increase in 5 days) prior to starting study treatment
* Has undergone gadolinium MRI or contrast CT scan within the past 14 days
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 mg/dL
* Transaminases ≤ 2.5 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to, during, and for 3 months after completion of study therapy
* Mini Mental State Exam score ≥ 15
* Able to swallow and retain oral medications
* No concurrent serious infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety
* No other malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
* No known uncontrolled seizure disorder (i.e., status epilepticus) or seizures occurring ≥ 3 times per week over the past month
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 10 days since prior cytochrome P450-inducing anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
* At least 1 week since prior biopsy or resection of tumor (for patients enrolled in the phase I dose-escalation/phase II portion of the study)
* No prior radiotherapy, chemotherapy, immunotherapy, hormonal therapy, or biological therapy (including immunotoxins, immunoconjugates, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) for treatment of brain tumor (for patients enrolled in the phase I dose-escalation/phase II portion of the study)
* Prior glucocorticoid therapy allowed
* No other prior chemotherapy or investigational agents (for patients enrolled in the phase I initial safety portion of the study)
* Prior Gliadel wafers allowed (for patients enrolled in the phase I portion of the study)
* No prior Gliadel wafers (for patients enrolled in the phase II portion of the study)
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Larry Kleinberg, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ABTC-0801
Identifier Type: -
Identifier Source: secondary_id
NABTT-0801
Identifier Type: -
Identifier Source: secondary_id
ABBOTT-M10-190
Identifier Type: -
Identifier Source: secondary_id
NABTT-0801 CDR0000616542
Identifier Type: -
Identifier Source: org_study_id
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