Protocol ID93-008 
Page 2 of 2 
Patient Evaluation: (Twenty lines not to exceed 75 characters pe r line) 
Physical examination, history, performance status, tumor status assessment, complete blood count, 
differential, platelets, chemistry survey (total bilirubin. SCOT. LDH. alkaline phosphatase, creatinine, 
BUN) Ca 125. vital signs, weight. PT and PTT. FEVi. ABGs. EKG. CXR cardiac stress test. UA and culture. 
HBs Ag. HIV. lymphocyte subpopulations, abdominal ascites for cytology, and DNA flow analysis. (These 
studies are required for the treatment protocol). 
Statistical Considerations: (Twelve lines not to exceed 75 characters per line) 
A justification is provided for undertaking a pilot study of 9 patients. PGR quantification in tumor zind 
normal control sites will be performed according to the analytic methods of Morgan et al. A successful 
outcome in this experiment is defined when the mean number of marked cells in tumor tissue is 
significantly larger than the mean number of marked cells in either the blood and the normal tissue. The 
mean referred to here is the average of the measurements taken in triplicate. If the first five patients 
exhibit a successful response, then there is significant evidence at the .05 level to reject the null hypothesis 
that the response rate is less than or equal to 1/2. In order to collect evidence that the probability of success 
is less than .30, 9 evaluable patients are needed. If all 9 patients have an unsuccessful outcome; i.e., the 
mean number of marked cells in tumor tissue is less than or equal to the mean number of marked cells in 
both the blood and the normal tissue, then there is evidence to reject the null hypothesis that the 
probability of success is greater than or equal to .30. 
Objectives: (Twelve lines not to exceed 75 characters per line) 
1. The feasibility of detecting CDO’^CDS'*' TIL-derived T cells that have been marked with the gene for 
neomycin phosphotransferase encoded in a safety modified retroviral vector (GlNa) at tumor sites after 
IP injection, and 
2. The fold of enrichment of CD3''’CD8''' marked TIL at tumor sites. 
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Recombinant DNA Research, Volume 19 
