Table 1 Patient Characteristics
HSPPC-96 Dose Level | Total | 2.5 μg | 25 μg | 100 μg |
|---|---|---|---|---|
Enrolled, no. | 36 | 11 | 16 | 9 |
Male, no (%) | 26 (72%) | 8 | 11 | 7 |
Median age (range), years | 54 (16-75) | 53 | 53 | 56 |
Karnofsky performance status | ||||
90% | 18 | 5 | 9 | 4 |
80% | 18 | 6 | 7 | 5 |
Prior treatment: no. of regimens | ||||
0 | 6 | 2 | 4 | |
1 | 19 | 8 | 8 | 3 |
2 | 4 | 1 | 1 | 2 |
≥ 3 | 7 | 2 | 5 | |
Prior treatment: type | ||||
IFN-α2 alone | 11 | 7 | 3 | 1 |
IL-2 alone | 2 | 1 | 1 | |
IFN + IL-2 | 2 | 1 | 1 | |
Chemotherapy + IFN + IL-2 | 18 | 4 | 10 | 4 |
Chemotherapy + IFN | 2 | 2 | ||
Systemic chemotherapy alone | 14 | 4 | 9 | 1 |
Elevated serum LDH level | 0 | 0 | 0 | 0 |
Serum level albumin <3.4 mg/dl | 0 | 0 | 0 | 0 |
Melanoma Characteristics | ||||
Regional nodal disease alone | 6 (17%) | 2 | 2 | 2 |
Regional nodal and in-transit disease | 5 (14%) | 2 | 3 | |
Advanced disease | 25 (69%) | 7 | 11 | 7 |
No. of visceral organs involved | ||||
0 (subcutaneous, nodal) | 5 | 2 | 1 | 2 |
1 | 14 | 2 | 7 | 5 |
2 | 6 | 4 | 2 | |
3 | 1 | 1 | ||
Visceral sites of disease | ||||
Lung alone | 10 | 1 | 4 | 5 |
Gastrointestinal tract alone | 2 | 2 | ||
Brain alone | 2 | 1 | 1 | |
Lung + 1 other visceral organ | 5 | 3 | 2 | |
Liver + 1 other visceral organ | 3 | 3 | ||
Brain + 1-2 other visceral organs | 2 | 2 | ||
HSPPC-96 derivation | ||||
Subcutaneous metastases | 7 | 1 | 6 | |
Lymph node metastases | 19 | 7 | 7 | 5 |
Lung metastases | 7 | 1 | 2 | 4 |
Liver or GI metastases | 3 | 2 | 1 | |
HSPPC-96 treatment setting | ||||
Indicators | 16 (44%) | 6 | 7 | 3 |
Stage III disease | 2 | 2 | ||
Stage IV disease | 14 | 6 | 5 | 3 |
Adjuvant | 20 (56%) | 5 | 9 | 6 |
Stage III disease | 9 | 4 | 3 | 2 |
Stage IV disease | 11 | 1 | 6 | 4 |