5. Hepatitis screen 
6. HIV screen 
7. 10 ml of clotted blood for serum storage (IFN-g and IL-6 levels) 
8. 45 ml of blood for mononuclear cell preservation. 
C. Urinalysis 
D. Chest X-ray 
E. EKG 
F. Baseline CT scan or MRI of brain, chest, abdomen, and pelvis to 
evaluate metastatic disease 
G. Merleux skin test for DTH reactivity. 
7.2 After Therapy: 
A. Physical examination at 24 hours after the first injection and then 
weekly after each injection which will include an assessment of the 
injection sites. 
B. Weekly blood tests (x 6) Including: 
1. 
CBC with differential 
and platelet counts 
2. 
Chemistries (see 
above) 
3. 
FT, PTT 
4. 
Serum (10ml) and 
PBMC 
(30ml) for storage 
C. Biopsy of vaccination sites on day 28. 
D. Merleux skin test for DTH reactivity at the time of biopsy. 
E. Appropriate radiographic and physical examination on day 60 and 90 to 
assess tumor response. 
8.0 CRITERIA FOR RESPONSE 
Patients will be assessed at one and two months following their fourth 
vaccination for evidence of tumor response using physical examination or 
radiographic studies. Responses at uninjected sites will be defined as 
follows : 
A. Complete response- disappearance of all measurable disease for at 
least 1 month without the development of new lesions. 
B. Partial response- 50% or greater decrease in the sum of the products 
of the perpendicular diameters of all measurable lesions lasting at 
least 4 weeks with no Increase in the size of existing lesions or 
appearance of new lesions. 
[658] 
Recombinant DNA Research, Volume 19 
