This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma.
\- This research study involves an experimental treatment called Niraparib.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must be ≥18 years of age.
* Participants must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation at time of initial diagnosis
* Participants must have radiographic evidence of progression/recurrence per RANO criteria for low grade gliomas (LGG) on MRI scan
* Participants must be willing and able to get serial MRI scans
* Participants must have surgically accessible tumors and be surgical candidates.
* Participants must be ≥12 weeks from completion of radiation to the CNS.
* Participants must have a baseline brain MRI scan within 21 days prior to Day 1 of treatment.
* Participants must be on a stable or decreasing dose of glucocorticoids for 7 days prior to registration.
* Patient must have Karnofsky Performance Score (KPS) ≥ 70
* Patient must have expected survival of ≥ 6 months.
* Participant must have adequate organ function, defined as follows:
* Absolute neutrophil count ≥ 1,500/μL
* Platelets ≥ 100,000/μL
* Hemoglobin ≥ 9 g/dL
* Calculated creatinine clearance ≥ 30 mL/min/1.73 m2 using the Cockcroft- Gault equation
* Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
* Patient must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or ot…