a study on Glioblastoma
BKM120 is a newly discovered drug that has been used in other research studies. Information from those other research studies suggests that BKM120 may help to slow or stop the growth of malignant gliomas. The purpose of this study is to see how well BKM120 works in patients with malignant gliomas. Patients on this study will be treated in two groups: patients who are going to receive surgery and those who will not receive surgery. This study is trying to determine how effective BKM120 is in stopping cancer cells from growing. For patients receiving surgery the research will also try to determine if an effective level of BKM120 can penetrate the brain before surgery.
A Phase II Study of BKM 120 for Patients With Recurrent Glioblastoma and Activated PI3K Pathway
For patients who will be having surgery, BKM will be taken orally for 8-12 days prior to surgery. Prior to surgery they will have a FDG-PET scan and during surgery a sample of tumor will be taken for research. Patients will resume oral BKM120 between 14 and 35 days after surgery.
For patients who are not having surgery and post-surgery patients, BKM120 will be taken orally for 28 days (1 cycle). Patients will continue on BKM120 as long as their brain tumor does not get worse and they do not have severe or intolerable side effects.
While on study, patients will have routine blood tests, a physical examination, and questionnaires to assess mood (each cycle), as well as an assessment of tumor by MRI or CT (~ every 8 weeks), and research blood samples at various timepoints for genetic studies and other tests that will measure any additional effect of the study drug and disease status. Participants may also be required to undergo a electrocardiogram and/or MUGA scan to monitor heart function during the study.
Glioblastoma BKM120 Brain tumor
Open to people ages 18 years and up
AND b)one of the following: i) At least 200 micrograms of frozen tissue OR ii)At least 10 (preferably 20) unstained FFPE sections of 10 micrometer thickness OR iii)At least 8 tissue cores from an FFPE block (200 micrometer total thickness of tissue from a block with a total surface area of 0.5 cm2)
Female partner of male study subject should use highly effective contraception while receiving study agent and for 16 weeks after final dose of study therapy.
Cohort 1 Inclusion Criteria (In addition to the general eligibility criteria, participants in the Cohort 1 preoperative portion of the study must meet the following criteria on screening examination to be eligible):
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