reactions should also be reported to the IRB. 
3. Side effects of IL-2 . A variety of side effects have been associated 
with IL-2 administration. We have had experience with the use of high-dose 
IL-2 either alone or in combination with cells or other cytokines in 1,039 
courses in 652 patients. A listing of the side effects and their incidence is 
presented in Table 8. 
TNF side effects including fever, chills, hypotension, oliguria, weight 
loss, nausea, vomiting and malaise. 
All side effects will be graded using the standard toxicity sheet used in 
all prior IL-2 related protocols presented in Table 9. 
4. Potential risks from injection of live tumor . These patients will 
receive the injection of approximately 0.1 gram of tumor into the skin or 
subcutaneous tissue of the anterior thigh. It should be emphasized that 
patients in this protocol will have histologically confirmed cancer with 
estimated tumor burdens of at least 10 grams or greater which is 50 times the 
amount of the tumor cells used for these immunizations. Based on our 
experimental data it is unlikely that these gene modified tumor cells will 
grow. These sites will be carefully monitored, however, and if tumor growth 
does occur then this site has been selected so that it could be widely excised 
with minimum morbidity. A small chance does exist, however, that if this site 
does grow that it might lead to spread of the injected tumor cells to draining 
lymph nodes or other sites in the body. The patients included in this 
protocol, however, will have metastatic cancer with limited life expectancy. 
The spread of the injected tumor is considered unlikely and in this patient 
population is unlikely to negatively influence the prognosis from their 
disease. 
If the gene modified tumor cells do grow and produce TNF, then patients 
will be exposed to this systemic TNF. The maximum amount the TNF produced by 
the transduced tumor lines is about 15 ng/10 6 cells/24 hrs. If the tumors 
grow at all then they will be allowed to grow to a maximum of about 2 x 10 9 
cells (or a 2 cm nodule) before they are excised. 2 x 10 9 cells will make 
Recombinant DNA Research, Volume 15 
[ 79 ] 
