The purpose of this study is to test the safety and efficacy of Boron Neutron Capture Therapy (BNCT) of Glioblastoma Multiforme (GBM). BNCT will be given alone or in combination with p-boronphenylalanine fructose (BPA-F), to patients 18 years of age or older with supratentorial, unifocal GBM. The objectives: 1.) To evaluate the safety of BPA-F at doses up to 495 mg/kg BPA in biodistribution studies. 2.) To evaluate the safety of BPA-F by increasing the BPA dose from 290mg/kg to up to 495 mg/kg in conjunction with the BCNT procedure. 3.) To evaluate the safety of increasing the average brain BNCT dose to =11.0 G~Eq. 4.) To evaluate the safety of increasing the BCNT peak brain dose to ~15Gy~Eq. 5.) To evaluate the safety of increasing the minimum target volume dose from 17 Gy~Eq to 29Gy~Eq. 6.) To evaluate the safety of one-versus two-fraction BNCT. 7.) To evaluate the safety of BNCT in patients with debulked versus nondebulked GBM. 8). To compare the safety of low-dose BNCT for primary GBM with the safety of BNCT in patients with recurrent GBM following BNCT, PRT (photon radiation therapy) and chemotherapy.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR010710-03
Application #
6408016
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1998-06-04
Project End
2001-11-30
Budget Start
Budget End
Support Year
3
Fiscal Year
2000
Total Cost
Indirect Cost
Name
State University New York Stony Brook
Department
Type
DUNS #
804878247
City
Stony Brook
State
NY
Country
United States
Zip Code
11794
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