Joint Clinical Trials Office

You are here

A071102: Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Clinical Trial Details

The purpose of this study is to examine brain cancer patients’ surgically removed tumors for certain molecular changes that may make them eligible to participate in the related treatment study. 

Before being enrolled onto the study for treatment, patients need to take part in the screening research study where the brain tumor will be tested to look at a small region of DNA called O6-methylguanine methyltransferase (MGMT). About a third of GBM tumors have a change in MGMT called methylation, and only patients with tumors that have MGMT methylation can participate in the treatment research study. If patient’s tumor does NOT have MGMT methylation, then patient cannot enroll onto this study.

After confirming that the patient has the MGMT mutation, they will be randomized onto one of two study arms: 
Group 1: usual chemotherapy drug (temozolomide) and a placebo pill 
Group 2: usual chemotherapy drug (temozolomide) plus a study drug called veliparib. 

Patients will receive either TMZ/placebo or TMZ/veliparib for just under 6 months. After the course of treatment is complete, the study investigator will follow up every 2-3 months for the first 3 years, and then at least every 6 months for years 4 and 5. 
   

Key Eligibility: 

   • Open to men and women age 18 and older 
   • Patients have not had a local MGMT testing 
   • Newly diagnosed Grade IV intracranial gliobastoma or gliosarcoma 
   • Patients must have completed standard radiotherapy and TMZ therapy 
   • No other therapy has been done (Neoadjuvant or adjuvant) which includes chemotherapy, biologics, immunotherapy, and radiation therapy. 
   • Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1510016674

ClinicalTrials.gov:

NCT02152982

Status

Open to Enrollment

Age Group

Adult

Sponsor