6.1.3 When 3 patients have successfully completed a dosage level without 
evidence of dose limiting toxicity, subsequent patients may be entered 
at the next dosage level. 
6.1.4 Cell administration will be as follows: 
Gene-modified tumor cells will be given by subcutaneous injection in 
Ringers solution with 5% HSA at weekly intervals x 2 and in amounts 
described in 6.1.5 in a volume of up to 1 ml. 
6.1.5 Cell dosage levels to be investigated on this schedule are: 
Day 1 
Day 8 
Level 1: 10 5 tumor cells/kg 
>10 6 cells/kg 
Level 2: 10 6 tumor cells/kg 
>10 7 cells/kg 
Level 3: 10 7 tumor cells/kg 
> 10 8 cells/kg 
Level 4: 10 8 tumor cells/kg 
>10 8 cells/kg 
6.2 Dosage modification (de-escalation) will be permitted for patients who develop 
dose limiting toxicity if these individuals have evidence of complete, partial or 
mixed response, or stable disease, and physician and patient desire to continue 
with a further treatment course (se section 6.0). 
6.3 Antiemetics in appropriate dosage for each patient will be prescribed as 
necessary. 
6.4 Patients will receive supportive care for acute or chronic toxicity, including blood 
components or antibiotics, and other intervention as appropriate. 
6.5 All treatments will be given at St. Jude Childrens’ Research Hospital. 
7.0 PATIENT EVALUATION 
7.1 A complete history and physical examination with documentation of measurable lesic 
(if present) is necessary prior to admission. 
f- 
7.2 Other Studies, Sequence 
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Recombinant DNA Research, Volume 15 
