) This application is the University of Texas Southwestern Medical Center (UTSW) proposal to continue participation in Phase I and 11 investigational drug trials in adults with anaplastic gliomas in a multi-institutional consortium, the North American Brain Tumor Consortium (NABTC). The ultimate purpose of this consortium is to identify agents and regimens with sufficient activity to justify definitive Phase III testing. In general, these Phase III trials will be conducted in larger groups in which the NABTC member institutions may participate. With this application, the NABTC is being reorganized and combined with another central nervous system tumor consortium, the NCNSC, to improve efficiency and accelerate accrual. Data management and statistical support for the consortium studies are being transferred to M.D. Anderson Hospital. The Contra Operations Office of the NABTC will continue to be the University of California at San Francisco. In three years, the NABTC has accrued 165 patients to four studies, including one completed protocol (9401) and three protocols nearing completion (9402, 9403, and 9404). Two LOI's for new protocols have been approved (9701 and 9702). The study coordinator for three of these six protocols (9404, 9701, and 9702) is the PI on this application. These and subsequent trials will include pharmacokinetic studies, which will continue to be performed at the University of Texas at San Antonio, and tissue banking for biological studies. Agents or regimens to be tested in subsequent Phase I and 11 trials of the NABTC will be selected during semiannual consortium meetings and will be based on: a) CTEP recommendations and preferences, b) pre-clinical experimental data from p a rticipant consortium institutions, and c) knowledge of the current literature with frequent interchanges about prioritizing potential new regimens. The newly reorganized NABTC estimates accrual of 60-80+ patients per year from the seven institutions that will be enrolling patients. This should allow completion of three to four trials per year, and pharmacokinetic (or other biologic) studies will be conducted on most, if not all, of these trials. UTSW participants in these consortium trials have been and will continue to be a multi-disciplinary team of neuro-oncologists, neurosurgeons, pediatric oncologists, radiation oncologists, and neuropathologists. UTSW is the only brain tumor research center in the north-central Texas region, and approximately 65 patients are enrolled on formal brain tumor protocols annually. With reorganization of the NABTC, we anticipate that a significant percentage of these will be enrolled on NABTC studies, which will be given highest priority within the institution.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA062455-07
Application #
6137536
Study Section
Special Emphasis Panel (ZCA1-CRB-K (O1))
Program Officer
Wu, Roy S
Project Start
1994-03-30
Project End
2002-12-31
Budget Start
2000-01-26
Budget End
2000-12-31
Support Year
7
Fiscal Year
2000
Total Cost
$98,195
Indirect Cost
Name
University of Texas Sw Medical Center Dallas
Department
Neurology
Type
Schools of Medicine
DUNS #
City
Dallas
State
TX
Country
United States
Zip Code
75390
Prados, Michael D; Yung, W K A; Wen, Patrick Y et al. (2008) Phase-1 trial of gefitinib and temozolomide in patients with malignant glioma: a North American brain tumor consortium study. Cancer Chemother Pharmacol 61:1059-67
Lamborn, Kathleen R; Yung, W K Alfred; Chang, Susan M et al. (2008) Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol 10:162-70
Kuhn, John G; Chang, Susan M; Wen, Patrick Y et al. (2007) Pharmacokinetic and tumor distribution characteristics of temsirolimus in patients with recurrent malignant glioma. Clin Cancer Res 13:7401-6
Cloughesy, Timothy F; Wen, Patrick Y; Robins, H Ian et al. (2006) Phase II trial of tipifarnib in patients with recurrent malignant glioma either receiving or not receiving enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol 24:3651-6
Cloughesy, Timothy F; Kuhn, John; Robins, H Ian et al. (2005) Phase I trial of tipifarnib in patients with recurrent malignant glioma taking enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol 23:6647-56
Chang, Susan M; Wen, Patrick; Cloughesy, Timothy et al. (2005) Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs 23:357-61
Puduvalli, Vinay K; Yung, W K Alfred; Hess, Kenneth R et al. (2004) Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study. J Clin Oncol 22:4282-9
Chang, Susan M; Kuhn, John; Wen, Patrick et al. (2004) Phase I/pharmacokinetic study of CCI-779 in patients with recurrent malignant glioma on enzyme-inducing antiepileptic drugs. Invest New Drugs 22:427-35
Chang, Susan M; Prados, Michael D; Yung, W K Alfred et al. (2004) Phase II study of neoadjuvant 1, 3-bis (2-chloroethyl)-1-nitrosourea and temozolomide for newly diagnosed anaplastic glioma: a North American Brain Tumor Consortium Trial. Cancer 100:1712-6
Prados, Michael D; Yung, W K Alfred; Fine, Howard A et al. (2004) Phase 2 study of BCNU and temozolomide for recurrent glioblastoma multiforme: North American Brain Tumor Consortium study. Neuro Oncol 6:33-7

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