Vistusertib (AZD2014) For Recurrent Grade II-III Meningiomas
United States28 participantsStarted 2017-10-17
Plain-language summary
This research study is studying a chemotherapy as a possible treatment for Meningiomas (recurrent).
The study intervention involved in this study is:
--AZD2014 (vistusertib)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically confirmed intracranial meningioma, grade II-III,that has recurred or progressed at previous treatment.
* Participants must be willing and able to undergo regular MRI scans of the brain.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm with MRI, performed within 30 days prior to study registration.
* Patients must have received prior surgical resection and radiation therapy for the progressive meningioma.
* Patients must have received less than three prior chemotherapy regimens for progressive meningioma.
* Patients must have available an archival paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
* Age ≥ 18 years at the time of study enrollment.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) with no deterioration over the previous 2 weeks.
* Life expectancy of greater than three months
* Within 14 days of study registration, participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* hemoglobin ≥90 g/L
* platelets ≥100,000/mcL
* total bilirubin ≤1.5 x institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* Serum creatinine ≤1.5 x institutional upper limit of normal concurr…