Summary:
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0 clinical trial to evaluate niraparib, a novel targeted therapy, in patients with newly diagnosed glioblastoma.
The goal of this Phase 0 study is to confirm that niraparib is capable of crossing the blood-brain barrier. Patients with positive results may advance to an expansion phase that combines therapeutic dosing of niraparib in combination with standard-of-care fractionated radiotherapy.
The expansion phase of this study will examine progression-free survival and monitor safety and tolerability of niraparib in combination with radiation.
- PARP (poly ADP ribose polymerase) is a protein that plays an important role in cell survival response to DNA damage.
- Niraparib (the treatment agent) is an oral, highly selective PARP inhibitor that blocks the tumor cell survival response.
- Niraparib is approved by the FDA for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Criteria:- You are 18 years or older
- You have a suspected newly diagnosed glioblastoma
- You plan on following the standard treatment regimen, including surgical resection and radiation
Qualified Participants May Receive:
As part of a clinical trial at the Ivy Brain Tumor Center, the study drugs will be provided free of charge, however, the patient and/or their health plan/insurance company will be responsible for some or all of the costs of treating the tumor in the study, including any standard medical care such as surgical resection.