low dose: 10 million tumor cells 
high dose: 50 million tumor cells 
13.3 The maximum tolerated dose will be defined as the dose of vaccine for 
which three or more patients have grade IV toxicity. The trial will be 
stopped at the determination of maximum tolerated dose or the completion 
of both dose levels. It is anticipated that a maximum tolerated dose may not 
be established in this study. 
14.0 CONSENT PROCEDURES 
All patients will be required to sign a statement of informed consent which must 
conform to IRB guidelines. This is included as appendix A. This research study has 
been reviewed by the IRB of Memorial Sloan-Kettering Cancer Center as well as the 
NIH Recombinant DNA Committee. The investigator will report to the IRB and the 
RAC changes in the research protocol and all unanticipated problems involving risks to 
human subjects or others, and no changes will be made in the research activity without 
IRB approval. 
Recombinant DNA Research, Volume 15 
[931] 
