Test/Eval Before During Before During After 
ChemoRx ChemoRX GeneRX GeneRX GeneRx 
HIV assay X 
Pregnancy Test X 
Marrow Asp./Bx X 
Lymph Node Bx X 
Peripheral Blood 
Sampling 2 X Q 2 wks Monthly 
1 Required for patients with a prior history of cardiac disease. 
2 40 ml of peripheral blood will be obtained for phenotypic and functional characterization of 
activated killer cells and to initiate cloning of subsets of killer cells. Samples will be obtained before, 
and every two weeks x4 during courses of gene therapy, and then monthly. 
Dr. Michael Kolber is conducting animal studies of the accelerated clearance of locally implanted 
radiolabeled transfected tumor cells as a surrogate marker for the generation of a cytocidal immune 
response. If the results of the initial studies are borne out by ongoing experiments in mice, we will 
employ this technique in our human studies. The initial injection of transfected tumor cells will be 
Indium labeled. Surface counts over the site of the forearm injection will be obtained by a gamma 
counter probe three times/week for the next two weeks to generate a curve of isotopic clearance. A 
subsequent injection using radiolabeled cells will be similarly evaluated to determine whether the 
transfected tumor cells injected later undergo more rapid clearance than the initially injected cells did. 
Correlation of these data with the results of in vitro tests of immunologic reactivity will be sought to 
confirm the value of this radiolabeled approach as a measure of immunologic response to transfected 
tumor cells. 
8.0 STATISTICAL CONSIDERATIONS 
The results of this approach to engineering an immune response to cancer will be evaluated 
clinically and in the laboratory. 
8.1 Clinical Response to Therapy 
At the time of treatment with gene transfected cells, patients will either be in complete or partial 
remission from therapy or will be relapsing from a previous complete or partial remission. The 
outcome for each group of such patients with conventional treatment is fairly predictable in a narrow 
range, in terms of progression-free and overall survival. If the gene transfected patients show a _> 50% 
prolongation of the intervals indicated below we will have highly suggestive evidence of a response. 
With conventional therapy, the approximate length of progression-free and overall survival for 
patients with limited stage disease based on disease status is as follows: 
Median Progression- 
Survjval Free Survival 
Complete Remission 16 months 12 months 
Partial Remission 12 months 9 months 
Relapsing 3-4 months 
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Recombinant DNA Research, Volume 18 
