This offering provides a single-institution proposal for Phase II and III development of anti-cancer agents. The University of Texas M.D. Anderson is comprised of disease-specific clinical cancer teams lead by physicians who have extensive backgrounds in the development of antineoplastic agents. These clinical teams include physicians involved in the treatment of melanomas, sarcomas, breast, gynecological, gastrointestinal, lung, head and neck, genitourinary, and neurological malignancies. Specific physician teams provide expertise in designing clinical trials in bone marrow transplantation and in the treatment of leukemias and lymphomas. To understand the basic science of anti-cancer agents under development at athe institution, laboratory correlative studies teams interact closely with the above clinical investigators. Areas of correlative laboratory investigation include analytical biochemistry, pharmacokinetic/pharmacodynamic studies, immunopharmacology, cellular pharmacology, cellular toxicity/lethality, and polyamine synthesis and inhibition. The clinical cancer and laboratory correlative studies teams are supported by a data management/quality control team which is comprised of a clinical trials support core (clinical trials administration, data management and quality assurance, data management support, and scientific=c review committee), biostatistics, and a research pharmacy (clinical materials handling and radiopharmaceuticals). Through the collaborative interaction of the above three teams, new anticancer agents which have undergone Phase I testing are further developed. The proposal provides a mechanism to determine the spectrum of activity of selected agents across a variety of human cancers, establish the role of new agents (or analogues), alone or in combination, and compare this role with standard therapies. In addition, approaches to Phase II/III development of high dose therapy using colony-stimulating factors, peripheral stem cells, or autologous bone marrow support are provided.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01CA070172-04S2
Application #
6318720
Study Section
Special Emphasis Panel (NSS)
Program Officer
Arbuck, Susan
Project Start
1995-08-01
Project End
2002-11-30
Budget Start
1998-04-07
Budget End
2002-11-30
Support Year
4
Fiscal Year
2000
Total Cost
$496,374
Indirect Cost
Name
University of Texas MD Anderson Cancer Center
Department
Radiation-Diagnostic/Oncology
Type
Other Domestic Higher Education
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030
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