Article Figures & Data
Tables
- Table 1
Patient characteristics
Serum CEA (ng/ml) Patient no. Age (yr)/sex Dosage (pfu) Performance statusa Primary site Metastatic disease Prestudy Week 8 Responseb 1 55 /M 107 1 Colon Liver 29 109 P 2 66/M 107 1 Rectal Liver, lung 154 288 P 3 59/M 107 0 Rectal Liver, lung 7 25 P 4 63/M 107 1 Colon Lymph nodes 5 2 P 5 65/M 107 1 Cholangiocarcinoma Peripancreatic 2 1 P 6 70/F 107 0 Colon Lymph nodes 188 166 S 7 73/M 107 1 Rectal Liver 41 91 P 8 64/F 107 1 Colon Lymph nodes 180 227 P 9 44/M 107 2 Cholangiocarcinoma Liver, lymph nodes 77 90 P 10 77/M 107 2 Colon Liver 3358 6820 P 11 77/F 108 2 Colon Liver, abdomen wall 45 45 P 12 49/F 108 1 Colon Liver, lung 103 168 P 13 75/M 108 0 Colon Liver, adrenal 1776 2933 P 14 62/M 108 1 Rectal Liver, peritoneal 554 919 P 15 42/M 108 1 Thyroid Mediastinum, bone 667 969 S 16 66/F 108 1 Rectal Liver, lung, nodes 39 44 S 17 53/F 108 0 Breast Peritoneum 33 42 P 18 71/M 108 1 Colon Liver 18 139 P 19 62/M 108 1 Gastroesophageal Lymph nodes 1 1 S 20 67/M 108 1 Colon Liver, lung 306 392 P -
a Performance status based on the Eastern Cooperative Oncology Group scale (0–4).
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b Response based on off-study evaluation on day 57. P, progressive disease; S, stable disease.
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- Table 2
Local inflammation at the inoculation site
Maximum diameter of erythema and/or induration (cm)a A. Patients receiving 107 pfu of rV-CEA per dose Group 1 (intradermal injection) Group 2 (Biojector) Patient no. 2 4 5 6 9 1 3 7 8 10 Postprime 3a 2P 1P 3 2P 5 6 4P 2P 1P Postboost 2 1 1 2 2 1 3 2 2 1 B. Patients receiving 108 pfu of rV-CEA per dose Group 3 (intradermal injection) Group 4 (Biojector) Patient no. 11 13 17 18 20 12 14 15 16 19 Postprime 4P 3P 4P 4P 3P 5 7P 6P 6P 3P Postboost 2 2 5 1 0 0 2 0 1 1 -
a Values are the maximum diameter (cm) of erythema and/or induration at the inoculation site 3–7 days following the dose. P, pustule formation.
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- Table 3
Lymphoproliferative responses to vaccinia virus
SIa A. Patients inoculated by intradermal needle injection Patient no. 2 4 5 6 9 11 13 17 18 20 Preimmunization 44 1 1 3 2 2 1 5 2 5 Week 4b 233 1 2 10 21 89 1 17 1 14 Week 8 753 1 33 729 488 478 27 668 1 23 B. Patients inoculated by Biojector Patient no. 1 3 7 8 10 12 14 15 16 19 Preimmunization 431 1 1 9 2 1 4 201 1 1 Week 4 582 670 2 37 16 40 51 1284 50 79 Week 8 8 331 271 41 158 114 1 4 2 7 C. Patients inoculated by scarification Patient no. A B C D E Preimmunization 1 1 4 5 2 Week 4 159 38 54 148 178 Week 12 137 10 1 49 51 -
a Values are SIs in response to UV-inactivated vaccinia virus.
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b Weeks after primary immunization.
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- Table 4
Mononuclear cell release of IL-2 in response to vaccinia virus
IL-2 (mIU/ml)a A. Patients inoculated by intradermal needle injection Patient no. 2 4 5 6 9 11 13 17 18 20 Preimmunization 35 0 1 9 0 0 3 11 0 0 Week 4b 40 0 0 11 80 135 1 4 0 22 Week 8 >300 0 4 >300 22 15 44 13 0 10 B. Patients inoculated by Biojector Patient no. 1 3 7 8 10 12 14 15 16 19 Preimmunization 63 1 0 0 0 0 13 43 0 0 Week 4 32 36 4 1 153 148 34 139 28 0 Week 8 >300 39 47 28 51 30 0 0 0 10 -
a Values are mIU/ml IL-2 in cell culture supernatant.
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b Weeks after immunization.
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- Table 5
Antibody response to vaccinia virus
Limiting dilution titer A. Patients inoculated by intradermal needle injection Patient no. 2 4 5 6 9 11 13 17 18 20 Preimmunization 10,000 −a 1,000 − − − 1,000 − − 3,000 Week 4b 10,000 30,000 10,000 3,000 10,000 10,000 10,000 10,000 10,000 10,000 Week 8 10,000 10,000 30,000 3,000 3,000 30,000 10,000 3,000 10,000 30,000 B. Patients inoculated by Biojector Patient no. 1 3 7 8 10 12 14 15 16 19 Preimmunization − − − − − 3,000 10,000 − − 1,000 Week 4 10,000 10,000 30,000 10,000 100,000 30,000 30,000 10,000 30,000 10,000 Week 8 10,000 3,000 30,000 3,000 100,000 100,000 30,000 3,000 30,000 10,000 -
a −, a negative result, referring to a limiting dilution titer of less than 1:300.
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b Weeks after immunization.
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Volume 5, Issue 9
