Niraparib In Recurrent IDH 1/2 Gliomas

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 other therapy intended for the treatment of cancer. (Patients with residual Grade 1 toxicity due to prior chemotherapy or alopecia of any grade are allowed).
• •Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
• •Female participant has a negative urine or serum pregnancy test within 3 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
• •* ≥45 years of age and has not had menses for \>1 year
• •* Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
• •* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
• •* Participant must agree to not breastfeed during the study or for 30 days after the last dose of study treatment.
• •Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 90 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
• •Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent