Clinical trial · Interventional
ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase I/II Trial of Temozolomide and ABT-888 in Subjects With Newly Diagnosed Glioblastoma Multiforme
NCT00770471CI-TRIAL-00033465completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: ABT-888 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. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with radiation therapy and temozolomide may kill more tumor cells. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pharmacogenomic studies |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- interventionNames
- Drug: temozolomide
- Drug: veliparib
- Genetic: DNA methylation analysis
- Genetic: gene expression analysis
- Genetic: mutation analysis
- Genetic: proteomic profiling
- Other: high performance liquid chromatography
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
- Other: mass spectrometry
- Other: pharmacogenomic studies
- Other: pharmacological study
- Procedure: adjuvant therapy
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Maximum tolerated dose of ABT-888 (Phase I)
- timeFrame
- continous
- measure
- Overall survival (Phase II)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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)References
Publications (0)
Data not yet available
No reference posted for this study.