Tests and Procedures 
<15 days 
prior to 
regis- 
tration 
During course of 
Rx days 3, 15, 
and 29^ 
Follow-up: at 8 wks 
post Rx and q 8 wks 
until PROG, 
then q 8-12 wks 
History and exam, tumor 
meas., ht, wt, KPS 
X 
X 
Xiu 
Vital signs (pulse, blood 
pressure, temperature) 
xi 
WBC, HgB, PLT 
X 
X 
X 
Chem-17, SGPT 
X 
X 
X 
PT,PTT 
X 
Days 15 and 29 
only 
Day 57 ^ 
EKG 
X 
Chest x-ray 
X 
CT scan and/ or 
ultrasound 
X« 
Days 15 and 29 
only 
X 
Tumor biopsy, guided by 
ultrasound 
Days 15 and 29 
only 
Days 43'^ and 57^^ 
j Urinalysis 
X 
HbAg, HTV titer 
X 
HLA-B7 phenotype 
x^ 
Assay for cytoxic T-cells 
and antibody^ 
X 
X 
Peripheral blood sample 
x^3 
Day 57 ^ 
1 Antinuclear antibodies 
X 
Day 29 only 
Day 57'/ 
1 Serum preg. test^ 
X 
1. Prior to each biopsy and treatment and then every 15 minutes until stable. 
2. Biopsy tissue will be assayed for the presence of the HLA-B7 gene by 
PCR. Expression of the HLA-B7 gene will be looked for 
immunohistochemically. When sufficient materials are present, attempts to 
assess the development of cytolytic T-cell response to the cells of the 
tumor will be evaluated. Tissue will be "snap" frozen in liquid nitrogen 
(LN) and sent in LN to a central lab facility. 
3. 45ml of clotted blood for serum storage and 45ml of anti coagulated blood 
for mononuclear cell cryopreservation will be obtained and sent to a 
central lab facility. 
4. 20ml of clotted blood will be obtained to look for development of 
antibodies, and 20ml of anti coagulated blood for mononuclear cell 
cryopreservation will be obtained and sent to a central lab facility. 
5. Only for patients receiving 2 or 3 injections of DNA on schedule B. 
6. For women of childbearing potential only. Must be done within 7 days 
prior to registration. 
7. Days 29, 43, and 57 are approximate. The goal will be to obtain the 
Recombinant DNA Research, Volume 19 
[215] 
