d. Concomitant medications 
f. Occurrence of secondary illnesses or 
malignancies and adverse experiences. 
6.5 Patient Death 
Patients who die while on the study will have an autopsy 
requested. 
7.0 TREATMENT ASSIGNMENT 
7.1 Patient Numbers 
After all the tests and evaluations in Section 6.1 have been 
completed and all general entry criteria satisfied, the patient may 
enter the treatment assignment portion of the study. The patient 
will be assigned a three digit identification number. Numbers 
will be assigned in strict sequential order. Once a number has 
been assigned to a patient, it cannot be reassigned if the patient is 
an early withdrawal from the study. Patients will be identified 
on case record forms only by their patient numbers and initials. 
The non-qualifier screening log must be completed stating the 
reason a patient failed to qualify for the study on all patients who 
sign an informed consent. 
8.0 TREATMENT ADMINISTRATION 
8.1 Autologous IL-2 GMT Administration 
8.1.1 Preparation and Storage of GMT 
Autologous tumor obtained from patients will be utilized 
to establish short term tumor cell cultures. The resultant 
cell culture will be transfected with Avectin™:IL-2. The 
gene modified tumor cells will be subjected to standard 
micro-biological testing. After lethal irradiation, the IL-2- 
expressing tumor cell will be aliquoted and maintained at 
-170° C in sealed vials. The IL-2 expressing tumor cell will 
then be thawed for re-injection into the same patient. A 
detailed characterization of the plasmid gene construct 
will be presented to the RAC and the FDA for approval 
prior to initiation of the study. 
8.1.2 Administration of GMT 
The patients will receive 1 x 10 7 tumor cells by 
subcutaneous injection that have been transduced with 
the IL-2 gene and irradiated with 10,000 RADS. Patients 
will receive subcutaneous GMT in single or multiple sites 
depending on volume to be administered. Vital signs will 
be taken prior to, 5 minutes after the injection and every 
15 minutes for 1 hour after the injection. 
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