4. Criteria for response . Complete response is defined as the dis- 
appearance of all clinical evidence of disease for at least four weeks. 
Partial response is defined as the 50% or greater decrease of the sum of the - 
products of perpendicular diameters of all lesions lasting at least four weeks 
with no increase in existing lesions or appearance of new lesions. Any patient 
having less than a partial response is considered to be non-responsive to 
treatment. 
POTENTIAL SIDE EFFECTS AND REPORTING OF ADVERSE REACTIONS . 
1. Adverse Drug Reaction Reporting will be performed in accord with NCI 
current reporting requirements for Phase I studies as follows: 
Report by telephone to IDB within 24 hours (301 496-7957, 
Available 24 hours) 
a. All life threatening events (Grade 4) which may be due to drug 
administration. 
b. All fatal events. 
c. The first occurrence of any previously unknown clinical event 
(regardless of Grade) 
Written report to follow within 10 working days to: 
Investigational Drug Branch 
P.O. Box 30012 
Bethesda, Maryland 20824 
2. Data will be submitted to CTMS at least once every two weeks. The NCI/ 
DCT Case Report of ACES will be used to report to CTMS. 
All adverse 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. 
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Recombinant DNA Research, Volume 14 
