are also maintained on ranitidine (150 mg orally bid) for prophylaxis against gastrointestinal 
bleeding. Patients receiving anti-hypertensive medications will have them discontinued 
during treatment with IL-2. 
Toxicities of treatment will be recorded daily during treatment and graded on a 0-4 
scale as defined by the NCI Common Toxicity Criteria (0 = no toxicity, 4 = life threatening, see 
Appendix I). For grade 4 toxicity, treatment will be discontinued. Based on our clinical 
experience and the experience reported by other groups. The dose modifications related to 
individual organ toxicity will be followed as indicated in Appendix J. Doses of IL-2 which are 
held will be restarted if the specific toxicity resolves to the next acceptable lower level. 
8.0 SIU.D.Y...PARAMETERS 
8.1 Pretreatment patient evaluation 
a. Complete history and physical examination 
b. Chem-21 blood chemistry panel 
c. CBC, differential, PT, PTT, platelet count 
d. Urinalysis 
e. HB s Ag, HTLV III Antigen 
f. Anti-DNA antibodies 
g. Chest CT scan 
h. Abdominal CT scan 
i. Head CT scan 
j. Bone scan 
k. Pregnancy test (if woman of child-bearing age) 
l. Stress myocardial function tests if clinically indicated 
m. PFT's if clinically indicated 
8.2 Ad.QPtiY,£_£elIular the r . a py/IL-2 administration 
Daily CBC, differential, platelet count, Chem-21 
8.3 Post-treatment patient evaluation 
a. History and physical examination with chest x-ray, Chem 21 , and CBC 
every month post-treatment until responsive status is determined. 
b. Chest and abdominal CT scan as appropriate to follow evaluable 
disease monthly for 2 months. 
8.4 Immunologic studies: will be performed pre and post treatment (1 and 2 
months after therapy) 
a. Recall skin tests: Merieux multi-test 
b. Cutaneous hypersensitivity to tumor: i.d. 1 0 4 , 10 5 and 10 6 irradiated 
tumor cells (10,000 cGy) in the contralateral extremity 
8.5 Assessment for adverse effects due to the retroviral transduced tumor cells 
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Recombinant DNA Research, Volume 18 
