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Niraparib for recurrent Glioma (grades II-IV)

About the glioma
clinical trial

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.

Click here for information on the study of niraparib for newly diagnosed glioblastoma patients.

Glioma Trial Details

Study Status

Recruiting

Treatment Agent(s)

Niraparib

Diseases

Recurrent grade II, III or IV glioma

Estimated Enrollment

18 Participants 

Clinicaltrials.gov identifier
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You may be eligible if:

  • 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 

View complete eligibility criteria by visiting ClinicalTrials.gov or call 602-406-8605 to speak with a patient navigator.

Phase 0 Clinical Trial: How it works

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Once enrolled, a patient receives a short exposure to the experimental therapy days before a planned operation to remove their tumor.


Glioblastoma Tumor Illustration

This exposure is enough that when we remove the tumor, our team of experts can answer an important question: Did the treatment have an effect on the tumor molecular targets? 


Combination Therapy for Gliboblastoma

If the drug impacts the targets at sufficient levels, the patient may move forward with receiving the treatment therapeutically in the expansion phase.


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Alternatively, if the treatment has no effect on the tumor, the patient can enroll in another clinical trial without losing time or receiving ineffective treatment.


Am I Eligible?

Submit a free trial screening request today to learn if you may qualify for a clinical trial or talk to an Ivy Navigator by calling 602-406-8605.

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