Glioma Treatment with Veliparib, Radiation and Temozolomide – Phase I/II

PBTC-033: ABT-888, an Oral Poly (ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children with Newly Diagnosed Diffuse Pontine Gliomas

Protocol Description

This Pediatric Brain Tumor Research Consortium trial is studying veliparib, also known as ABT-888, when given with radiation therapy and temozolomide (TMZ) in treating young patients with a type of brain stem tumor called a diffuse intrinsic pontine glioma (DIPG). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, while radiation therapy uses high-energy X-ray beams to kill tumor cells, and TMZ can help prevent tumor growth by killing tumor cells or stopping them from dividing.
Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages up to 21 years old, recently diagnosed with DIPG.
Males and Females: Up to 21 years old

Requirements

Participants will take veliparib daily during radiation for 6 to 7 weeks followed by a “rest period” of 3 to 4 weeks in which no medication is taken. Beginning with week 11, the participant will receive maintenance therapy consisting of veliparib with TMZ for 5 days every 28 days for a total of 10 courses. Extended therapy of up to an additional 13 courses may be considered depending on the outcome after the initial test period.
Visits: Weekly for 6 weeks during radiation therapy, then monthly for chemotherapy for 10 months
Duration: 1 year for treatment with follow-up for up to 3 years

Status: Open for Enrollment

Source(s) of Support

Pediatric Brain Tumor Consortium (Study PBTC-033)
National Cancer Institute

Primary Investigator

A. Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864