10.4 
the Taxol will be stopped for that patient. If Grade I' 
hematopoietic toxicity is encountered in two successive courses* 
of Taxol despite does reductions of Taxol in between, the Taxol® 
despite dose reduction will be stopped for that patient. 
Reporting Requirements: Reports will be submitted to the NIH RACB 
every 6 months and to CTEP on the CTEP ADU forms every 4 months.® 
Serious adverse events will be reported to the NIH RAC, to the® 
CTEP, and to the FDA. ■ 
1. Ozols, R.F. et al. J. Clin. Oncol. 2*1246, 1985. 
2. Canetta, R.M. et al. J. Cancer Res. Clin. Oncol. 107 : 111 . 1984. 
3. Schurs, E. , Raymond, M. , Bell, J.C., and Gros, P. Cancer Res. 49:2729 
2734, 1989. 
4. Devault, A. and Gros, P. Mol. Cell. Biol. 20:1652-1663, 1990. 
5. Ueda, K. , Cardarelli, C. , Gottesman, M. , and Pastan, I. Proc. Natl. 
Acad. Sci. USA M:3004-3008, 1987. 
6. Williams, S. , Mich, R. , Desser, R. , et al. J. Clin. Oncol. 1 : 1824, 
J. , Gottesman, M. , and Pastan, I. J. Natl. Cancer Inst. 81 : 116-124 
1989 . 
Willingham, M. Proc. Natl. Acad. Sci. USA 85:4486, 1988. j 
9. Belmont, J. , MacGregor, G. , Wager-Smith, K. , Fletcher, F. , Moore, 1 
K.A., Hawkins, D., Villalon, D. , Chang, S., and Caskey, T. Mol. Cell." 
Biol. 8:5116-5125, 1988. j 
10. Lim, B. , Apperly, J. , Orkin, S., and Williams, D.A. Proc. Natl. Acad.^ 
Sci. USA 86:8892-8896, 1989. j 
11. Podda, S., Ward, M. , Himelaten, A., Richardson, C. , Delof lor-Weiss , E. ,' 
Smith, L. , Gutterman, M. , Pastan, I., and Bank, A. PNAS 89:9676-9680,^ 
1992. j 
12. Storb, R. UCLA Gene Therapy Meeting, Copper Mountain, NY, September, 
1992. 
13. Bodine, D. UCLA Gene Therapy Mtg. , Copper Mountain, NY, Sept., 1992. 
14. Sorrentino, B. , Brandt, S., Bodine, D., Gottesman, M. , Pastan, I., 
Cline, A., and Nienhuis, A. Science 257 :99. 1992. 
15. Kasid, A., Morechi, S., Aebersold, P. , Cornetta, K. , Culver, K. , 
Freeman, S., Director, E. , Lotze, M.T., Blaise, R.M., Anderson, W.F., 
and Rosenberg, S. Proc. Natl. Acad. Sci. USA 82:473-477, 1990. \ 
16. Claxton, D. , Suh, S.-P., Filaccio, M. , Ellerson, D. , Gaozza, E. , 
Andersson, B. , Brenner, M. , Reading, C. , Feinberg, A., Moen, R. , 
Belmont, J. , Moore, K. , Talpaz, M. , Kantarjian, H. , and Deisseroth, A. 
Human Gene Therapy 2:317-321, 1991. 
17. Etkin, M. , Filaccio, M. , Ellerson, D. , Suh, S.-P., Claxton, D. , Gaozza, 
E. , Brenner, M. , Moen, R. , Belmont, J. , Moore, K. , Moseley, A.M., 
Reading, C. , Khouri, I., Talpaz, M. , Kantarjian, H. , and Deisseroth, A. 
Human Gene Therapy 2:137-145, 1992. 
18. Deisseroth, A., Kantarjian, H., Talpaz, M. , Champlin, R. , Reading, C. , 
Andersson, B., and Claxton, D. Human Gene Therapy 2:359-376, 1991. 
19. Moore, K.A. , Deisseroth, A.B., Reading, C.L., Williams, D.E., and 
Belmont, J.W. Blood 79:1393-1399, 1992. 
REFERENCES 
1989 . 
7. Goldstein, L. , Golski, H. , Fojo, A., Willingham, M. , Lai, S., Gadzar 
A., Pirkin, R. , Green, A., Crist, W. , Brodeau, G. , Lieber, M. , Cassan 
8. Pastan, I., Gottesman, M. , Ueda, K. , Lovelace, E. , Rutherford, A., and 
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