Table 1.
Patient characteristics
| Patient | Sex | Age (yrs) | Stage | Site of disease | LDH (U/l) | Gp100d | Tyrosinased | No. of vac. |
|---|---|---|---|---|---|---|---|---|
| Patients with distant metastatic melanoma | ||||||||
| DE-01 | f | 40 | M1c | lung, LN, spleen, pancreas, adrenal | 340 | +++ | ++ | 3 |
| DE-02 | f | 71 | M1ca | lung, LN, adrenal | 447 | +++ | +++ | 9 |
| DE-03 | m | 44 | M1c | liver, lung, LN, skin, spleen | 365 | +++ | ++ | 3 |
| DE-04 | m | 68 | M1c | liver, lung, skin, bone | 441 | +++ | + | 3 |
| DE-05 | f | 46 | M1a | LN | 334 | +++ | +++ | 3 |
| A-01 | f | 49 | M1ca | liver | 424 | + | + | 3 |
| A-03 | f | 44 | M1c | liver, lung, LN, kidney, subcutaneous | 504b | +++ | + | 3 |
| A-04 | f | 47 | M1ca | cardia, muscle, sigmoid | 440 | +++ | + | 9 |
| A-08 | m | 71 | M1a | LN | 395 | +++ | ++ | 3 |
| Patients with resected regional metastatic melanoma (stage III) | ||||||||
| A-02 | f | 37 | N1b | LN | 268 | +++ | +++ | 8e |
| A-05 | m | 62 | N3 | LN, in transits | 652c | +++ | +++ | 3 |
| A-06 | m | 70 | N2b | LN | 342 | ++ | ++ | 3 |
| A-09 | f | 59 | N1b | LN | 297 | +++ | ++ | 9 |
| A-10 | m | 64 | N2b | LN | 297 | +++ | +++ | 9 |
a
Primary uveal melanoma.
b
LDH normalized before first vaccination (upper limit of normal 450 U/L).
c
LDH normal at screening (441), increase due to rapid progressive disease.
d
gp100 and tyrosinase expression on the primary tumor or metastasis was analyzed by immunohistochemistry. Intensity of positive cells were scored centrally and semi-quantitatively by a pathologist. Intensity was scored as low (+), intermediate (++), or high (+++).
e
Too little viable cells to complete last cycle of vaccinations.
LN, lymph node.