to 40 units of IL-2 per 10^ cells per 24 hours. This will result in the administration of approximately 1.25 
X 10^ transduced cells for the initial immunizations depending upon the level of IL-2 expression measured 
in vitro per 10^ cells over 24 hours. We plan to escalate the dose of IL-2 secreting cells, as follows: 
Cohort 
Number of Patients 
Units of IL-2 
# Transduced Cells 
1 
3 
25 
1.25 X 10^ 
2 
3 
50 
2.5x 106 
3 
3 
100 
5.0x 106 
4 
3 
200 
l.Ox 107 
5 
3 
400 
2.0x 107 
The transduced cells will be mixed with unmodified irradiated tumor cells resulting in a total tumor cell 
dose of 1 X 10^ cells. The dose of transduced cells will be escalated when 3 patients at each dosage level 
have been treated and followed for I month without > grade 3 toxicity. Toxicity grades are listed in 
Appendix 12.1 of the original protocol. Hence, we plan to study 15 patients with autologous transduced 
tumor injections and 15 patients with injections of the transduced allogeneic glioblastoma cell line GT9. 
If 3 patients at the same dosage level develop unacceptable treatment related toxicity (> grade 3 toxicity), 
the study will continue at the previous dose level until three additional patients have been treated. The 
treatment of additional patients at the lower dosage level will permit further assessment of the effects of 
transduced cell injections at the lower dose. These parameters define the Phase I study. 
However, if significant anti-tumor effects are observed in a given patient (>50% tumor reduction ) it may 
be improper to withold further treatment if additional cells are available for immunization. These 
additional immunizations would be administered at 2 week intervals, at the discretion of the investigators, 
as warranted by the demonstration of anti-tumor immune responses and improvement in the patient's 
clinic status. 
7.2 Maximum Tolerated Dose (MTD) 
The MTD is defined as that dose of IL-2 secreting cells which results in > grade 3 toxicity or which 
causes a delay in day 14 immunization in > 3/6 patients in any treatment cohort. Day 14 treatments must 
be delayed if any > grade 2 toxicity has not reversed to < grade 1 . 
8.0 Study Parameters 
8.1 Pre-treatment Evaluations 
The following pre-treatment evaluations will be performed (8.1 1-8.14): 
8.1.1 History and Physical Examination 
These evaluations will include a description and quantitation of disease activity. 
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