The primary objective of the study is to determine the safety of 2 IV injections of autogously derived EBV specific cytotoxic T-lymphocytes that have been marked with the Neomycin resistnace gene introduce by a retroviral vector. The two injections will be given at day 0 and day 14 and the three dose levels of interest are discussed in Section 6.1 of the protocol. Buring the coused of the study, the survival, immunological efficacy and anti-tumor activity of neomycin resistance gene marked EBV specific cytotoxic T-lymphocyte lines will also be studied. This is a classical phase I study to obtain the optimal dose level in a dose escalation trial. The results of this study will not be definitive but only suggestive and a Phase II trial will be undertaken to study the efficacy of the treatment after determining the safe dose level.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000188-37
Application #
6421317
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
37
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Baylor College of Medicine
Department
Type
DUNS #
074615394
City
Houston
State
TX
Country
United States
Zip Code
77030
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