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 recurrent WHO Grade II, III, or IV glioma with IDH1 or IDH2 mutation and ATRX loss.
The goal of this Phase 0 study is to evaluate the impact of niraparib on the tumor molecular targets. Patients with positive results may advance to an expansion phase and receive niraparib therapeutically.
The expansion phase of this study will examine progression-free survival and monitor safety and tolerability of niraparib.
- 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 had a prior resection of histologically diagnosed WHO grade II-IV glioma with IDH1 or IDH2 mutation and ATRX loss
- Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed) and you require resection as part of your treatment plan
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.