Research

CNS Tumor Treatment with ABT-888 and Temozolomide – Phase I

ABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors

Protocol Description

This Pediatric Brain Tumor Research Consortium Phase I trial is studying the side effects and best dose of ABT-888 when given in combination with temozolomide in treating young patients with recurrent or refractory central nervous system (CNS) tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, up to age 21, who have been diagnosed with a primary CNS malignancy that has come back (recurrent) or refractory (resistant) to standard therapy and for which there is no known curative therapy.
Males: Up to 21 years
Females: Up to 21 years

Requirements
Participants will be provided up to 13, 4-week courses of therapy, that begin with oral doses of ABT-888 twice daily and temozolomide once daily for 5 days. Participants who are benefitting from the treatment at the end of the13 courses may optionally be provided course continuation for an additional 13 courses. Blood testing and MRI scans will be conducted as part of the treatment.
Frequency of visits: Weekly for blood testing
Duration: Up to 26, 4-week cycles.

Status: Open for Enrollment

Source(s) of Support
Pediatric Brain Tumor Research Consortium (Study PBTC-027)
National Cancer Institute

Additional Resources
Study Description at National Institutes of Health