Study:
A Phase I/II Trial of Temozolomide and ABT-888 in Subjects With Newly Diagnosed Glioblastoma Multiforme
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Brain and Central Nervous System Tumors |
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 |
Phase 1/Phase 2 |
Verified by
Sidney Kimmel Comprehensive Cancer Center
May, 2012
Sponsored by: Sidney Kimmel Comprehensive Cancer Center
Information provided by: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT00770471
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Larry Kleinberg, MD., Principal Investigator