Table 1.
Patient characteristics
| No. | Age/sex | Ethnicity | Perf. status (%) | Tumor site | Histology | Recurrence | Prior chemo | Prior XRT | Prior surgery | Non-target lesions | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (3 × 1011 VP + 15 mg/m2) | 1 | 54/F | Caucasian | 80 | Neck | SCC—mod diff. | Regional | Y | Y | Y | N |
| 2 | 55/M | Caucasian | 90 | Neck | Adenoid cystic ca. | Regional | Y | Y | Y | Y | |
| 3 | 59/M | Caucasian | 80 | Neck | SCC | Regional | Y | Y | Y | N | |
| Cohort 2 (3 × 1011 VP + 45 mg/m2) | 4 | 65/M | Caucasian | 70 | Cheek | SCC | Local | Y | Y | Y | Y |
| 5 | 60/M | Caucasian | 90 | Hard palate | Adenoid cystic ca. | Regional | Y | Y | Y | Y | |
| 6 | 65/M | Caucasian | 100 | Tonsil | SCC | Local | Y | Y | Y | N | |
| Cohort 3 (3 × 1011 VP + 75 mg/m2) | 7 | 61/F | African-American | 80 | Neck | SCC—poor diff. | Local | Y | Y | Y | N |
| 8 | 53/M | Caucasian | 90 | Neck | SCC—poor diff. | Local | Y | Y | Y | Y | |
| 9 | 56/M | Caucasian | 70 | Neck | SCC | Local | Y | N | Y | Y | |
| Cohort 4 (2.7 × 1012 VP + 75 mg/m2) | 10 | 64/F | Caucasian | 70 | Lower lip | SCC—mod diff. | Local | Y | Y | Y | N |
| 11 | 82/M | Caucasian | 70 | Scalp | Melanoma | Distant | Y | Y | Y | Y | |
| 12 | 64/M | Caucasian | 100 | Lower ext. | Nevoid melanoma | Local | N | Y | Y | Y |
Patients enrolled in this study are listed by cohort, age, sex, ethnicity, performance status, cancer type, site, treatment history, and presence of non-target lesions. Doses of fludarabine are listed by body surface area (mg/m2).
VP, viral particles; SCC, squamous cell carcinoma; Ca., carcinoma; Perf. status, Performance status; mod diff., moderately differentiated; poor diff., poorly differentiated.