five years after transplant: 2 x 10* cells for MDR-1 PCR, 2 x 10^ 1 
blood and marrow cells for viral PCR, 2 x 10* cells for NIH3T3 ■ 
viral amplification studies, 1 x 10^ cells for Southerns and 10 
cc of a red top tube for Western blots for viral antibodies. 
7.7 At the time of relapse, samples of the tumor, obtained as part of 
staging procudures used to document the relapse, will be analyzed 
for the presence of the viral MDR-1 by PCR assay. 
8.0 CRITERIA FOR RESPONSE AND TOXICITY (SEE APPENDIX E) 
8.1 Criteria for toxicity will be as follows: Failure of the 
autologous cells to engraft to 500 PMN/cu mm by 30 days and the 
need to use back-up collections of hematopoietic cells from the 
marrow or peripheral blood for reconstitution. 
8.2 Disordered hematopoiesis, abnormal morphology and alteration of 
the ratio of myeloid to erythroid cells will be established by| 
morphology every three months as outlined in Appendix F. 
8.3 Neurotoxicity or mucositis (Grade IV) in 3 consecutive patients 
will be grounds for decreasing the Taxol dose. 
8.4 We will use NCI Investigational Agent Drug Reporting Criteria 
(see chart in Appendix E) and will report any Grade IV toxicity 
on this protocol to the FDA as well as to the Protocol and 
Information Office (Executive Plaza, North, Room 730, Bethesda, 
Maryland 20892) . 
8.5 CRITERIA FOR RESPONSE 
All tumor measurements must be recorded and must have the longest 
diameter and its perpendicular, applied at the widest portion of 
the tumor, recorded. The antitumor activity of the drug under 
study will be evaluated according to the following responsei 
criteria: 
a) Complete Remission (CR) : Disappearance of all clinical 
evidence of active tumor for a minimum of 4 weeks. 
b) Partial Remission fPR^ : 50% or greater decrease in the sum 
of the products of the diameters of measured lesions. No 
simultaneous increase in the size of any lesion or the 
appearance of new lesions may occur. This improvement must 
continue for 4 weeks to be considered a partial remission. 
c) Minor Change: Same as partial remission but tumor regression' 
is <50%. 
d) No Change (NO : No change. 
e) Progressive Disease fPD) : Increase of at least 25% in the 
size of any measured lesion or appearance of one or more new 
lesions . 
f) Minor change, no change and progressive disease will be 
considered as failure to therapy. 
9.0 CRITERIA FOR REMOVAL FROM STUDY j 
[536] Recombinant DNA Research, Volume 19 ^ 

