6.2.5 Chemotherapy , other immunotherapy , radiotherapy , and hormonal therapy 
must be excluded during participation in this clinical trial. 
6.2.6 Glucocorticosteroids may abrogate the effectiveness of rIL-2 therapy. 
These agents should be excluded during and for one week preceding entry 
into this trial (except for life-threatening symptoms). 
7. STUDY MEDICATION DESCRIPTION 
7.1 Interleukin-2 (rIL2) 
The gene for rIL-2 (Ro 23-6019) is derived from the human lymphoblastoid T-cell 
(JURKAT), and the rIL-2 protein is produced by Escherichia coli RR1 containing 
the plasmid RC233/IL-2. 
Highly-purified Roche rIL-2 has a natural sequence and appears to be composed 
of greater than 95 percent of one protein species. Purified rIL-2 has a molecular 
height of 15,500 daltons, as estimated by mobility measurements on SDS- 
polyacrylamide gel electrophoresis (when compared to known molecular weight 
standards). The calculated molecular weight based on its amino acid sequence is 
15,420 daltons 12 . 
The rIL-2 is supplied powder in sterile 5 ml vials. The vials will be supplied with 
varying amounts of rIL-2 which may be reconstituted with sterile, preservative 
free, isotonic saline in a volume of 1 ml. 
This volume is then further diluted in 500 ml to 1000 ml of normal saline for 
infusion over 24 hours. The reconstituted solution is stable for 24 to 36 hours at 
room temperature. The rIL-2 is not stable when reconstituted in a 5 percent 
dextrose solution, therefore 5 percent dextrose should not be used as a diluent. 
7.2 Recombinant interferon alpha 2a . (IFNaA) 
Ro 22-8181/002 
Roferon R -A is supplied as either a lyophilized powder or solution for injection in 
sterile 3 or 5 ml vials. A vial will contain approximately 3 X 10 6 or 18 X 10 6 
units of Roferon R -A. The lyophilized powder should be reconstituted just prior 
to use because it contains no bacteriostatic agent. Any unused material, whether 
reconstituted or injectable solution should be discarded. Store unused, lyophilized 
powder in the refrigerator or freezer (-4 to +46° F, -20° to +8°C. When 
Roferon R -A is supplied as an injectable solution, store in the refrigerator (+36° 
to +46° F, +2° to +8° C). The injectable solution should not be frozen. 
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Recombinant DNA Research, Volume 15 
