Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma

Summary

RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 veliparib together with temozolomide may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of giving veliparib together with temozolomide and to see how well it works in treating patients with recurrent glioblastoma.

Conditions

• Brain and Central Nervous System Tumors

Interventions

DRUG

temozolomide 60 mg x 21 days

Temozolomide 60 mg/m2 x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.

DRUG

temozolomide 75 mg x 21 days

Temozolomide 75 mg/m2 x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.

DRUG

ABT-888 20 mg x 21 days

20 mg bid x 21 days, with a 28-day cycle. Treatment will continue until progressive disease unless toxicity or the discretion of the treating physician precludes further therapy.

DRUG

ABT-888 40 mg x 21 days

40 mg bid x 21 days/28-day cycle. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude further therapy

DRUG

Temozolomide 150 mg x 5 days

150 mg/m2 x 5 days (up to 200 mg/m2 after 2nd cycle)\*, with a 28-day cycle; dose reduction to 125 mg/m2 if necessary. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude

DRUG

ABT-888 40 mg x 5 days

40 mg bid x 5 days/28-day cycle. Treatment continues until progressive disease unless toxicity or the discretion of the treating physician preclude

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• H. Ian Robins, MD, PhD · University of Wisconsin, Madison

• Mark R Gilbert, MD · National Cancer Institute/National Institutes of Health

• Arnab Chakravarti, MD · Arthur G. James Comprehensive Cancer Center and Richard J. Solove Research Institute, Ohio State University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2014-05-31

Completion

2016-12-31

FDA Drug

Yes

Countries

• United States

Study Locations