Veliparib and Temozolomide in Treating Patients With Recurrent Glioblastoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

May 31, 2014

Study Completion Date

December 31, 2016

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

Trial Locations (17)

14620

Highland Hospital of Rochester, Rochester

14642

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

40202

Louisville Oncology at Norton Cancer Institute - Louisville, Louisville

66208

CCOP - Kansas City, Prairie Village

89502

Renown Institute for Cancer at Renown Regional Medical Center, Reno

90048

Cedars-Sinai Medical Center, Los Angeles

96706

Leeward Radiation Oncology, ‘Ewa Beach

96813

Cancer Research Center of Hawaii, Honolulu

Queen's Cancer Institute at Queen's Medical Center, Honolulu

96817

Hawaii Medical Center - East, Honolulu

97210

Legacy Good Samaritan Hospital & Comprehensive Cancer Center, Portland

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

60637-1470

University of Chicago Cancer Research Center, Chicago

40503-9985

Central Baptist Hospital, Lexington

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

08903

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK