This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a Phase I study of bortezomib and temozolomide in subjects with a recurrent primary brain tumor (including primary CNS lymphoma) or recurrent brain metastases or confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.The objectives of this study are:1.1 To determine the dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) for the combination of bortezomib and temozolomide in patients with recurrent high-grade gliomas, recurrent metastatic brain tumors or other refractory solid tumors.1.2 To evaluate the pharmacokinetics of bortezomib in patients taking hepatic enzyme-inducing anticonvulsants (Group A) and in those who are not (Group B).1.3 To assess whether bortezomib crosses into the central nervous system by measuring drug levels in the cerebrospinal fluid.1.4 To describe the proportion of study patients treated with bortezomib and temozolomide who obtain a confirmed complete response or partial response.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000043-48
Application #
7716648
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2008-04-20
Project End
2008-11-30
Budget Start
2008-04-20
Budget End
2008-11-30
Support Year
48
Fiscal Year
2008
Total Cost
$108,156
Indirect Cost
Name
University of Southern California
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
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Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Cooper, Aaron R; Lill, Georgia R; Shaw, Kit et al. (2017) Cytoreductive conditioning intensity predicts clonal diversity in ADA-SCID retroviral gene therapy patients. Blood 129:2624-2635
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93

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