3. Sterility will be assured by testing for aerobic and anaerobic 
bacteria, fungus and mycoplasma. 
4. S+/L- assay including 3T3 amplification must be negative. 
5. PCR assay for the absence of 4070A envelope gene must be negative. 
6. Reverse transcriptase assay must be negative. 
7. Southern blot will be run on the transduced TIL to assure that intact 
provirus is present. 
8. IL-2 will be withdrawn ffrom the culture medium of an aliquot for at 
least one week to assure that cells do not exhibit autonomous growth 
in the absence of IL-2. 
9. Cytotoxicity against the autologous and at least two other targets will 
be tested. The phenotype of the cells will be tested by flow 
cytometric analysis. 
The S+/L- assay, the 3T3 amplification assay and the polymerase chain 
reaction assay are detailed in Appendix C. 
PATIENT EVALUATION 
Parameters to be Measured 
Pre During Therapy Week 
Studv 
D3 
D5 
D6 
D15 
D17 
D19 
D20 
7 
Physical exam 
X 
X 
History 
X 
X 
X 
Performance Status 
X 
X 
Assess for Antitumor 
Effect' 
X 
X 
Chemistry Survey^ 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC, Diff, Platelet 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PT, PTT 
X 
X 
X 
X 
X 
X 
FEVl, ABCs 
X 
EKG 
X 
X 
X 
CXR 
X 
X 
X 
X 
X 
Cardiac Stress Test 
(pts>50) 
X 
U/A and Culture 
X 
HbsAg, HIV Ab 
X 
Brain CT or MRI 
X 
Assess for adverse 
events status 
X 
PCR on PBL to detect 
Neo gene 
X 
X 
X 
X 
X 
X 
Tumor biopsy 
(if feasible) 
X 
X 
X 
X 
X 
Western blot 
(4070A envelope) 
(in TIL pts) 
X 
X 
4 
To include assessment of all sites of disease. 
^Includes total bilirubin, SCOT, LDH, Alkaline Phosphatase, Creatinine, Bun, CPK 
Recombinant DNA Research, Volume 14 
[845] 
