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.ABSTRACTHYPOTHESISThe combination of irinotecan, temozolomide and vincristine will be well tolerated and will have synergistic anti-tumor activity.
SPECIFIC AIMS To estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose of oral irinotecan when administered with fixed-dose temozolomide and vincristine to children with refractory solid tumors or brain tumors.To define the toxicities of the above drug combination when administered on this schedule, and to describe any differences in toxicities between patients with low vs. high-risk UGT1A1 genotypes.To characterize the pharmacokinetics of oral irinotecan in children with refractory cancer who are receiving temozolomide and vincrisine.SECONDARY AIMSTo preliminarily define the antitumor activity of this drug combination within the confines of a Phase 1 study.To describe the relationship of UGT1A1, UGT1A7, UGT1A9, and BCRP genotypes to the pharmacokinetics and pharmacodynamics of irinotecan metabolites.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000188-43
Application #
7605913
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-02-15
Project End
2007-11-30
Budget Start
2007-02-15
Budget End
2007-11-30
Support Year
43
Fiscal Year
2007
Total Cost
$7,322
Indirect Cost
Name
Baylor College of Medicine
Department
Pediatrics
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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