This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Clofarabine has been demonstrated in several Phase II studies to have significant activity in patients with relapsed or refractory acute myeloid leukemia, with a response rate as a single agent in the range of 30-40%. There is also evidence of a significant, synergistic interaction with ARA-C in vitro (the most important drug in the treatment of AML). Clofarabine appears to have more activity in patients with relapsed (as opposed to refractory) AML, and it is therefore anticipated that its activity will be greater in patients with de novo disease than those with relapsed disease. A Phase I/II study of Clofarabine with intermediate dose (as opposed to a standard lower dose, as will be given in UAB 0341) ARA-C has shown the combination to be well tolerated and to have clinical activity in patients with relapsed disease. We therefore anticipate that, in addition to the single agent activity of Clofarabine, it will have a synergistic cytotoxic effect with ARA-C, and possibly overcome chemoresistance in patients with AML (ie. improve the complete remission rate). To investigate this effect, we will be monitoring the intra-cellular pharmacokinetics of Clofarabine and ARA-C together, to determine whether this synergistic effect occurs in vivo.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-46
Application #
7380451
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-03-01
Project End
2007-02-28
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
46
Fiscal Year
2006
Total Cost
$4,935
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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