ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Summary

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

• Brain and Central Nervous System Tumors

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  lead OTHER

Principal Investigators

• Larry Kleinberg, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-13

Primary Completion

2012-03-01

Completion

2012-03-01

FDA Drug

Yes

Countries

• United States

Study Locations