Table 1: Proposed treatment scheme.
|
Agent (mg/ml) |
Volume (ml) |
Way |
Schedule (week) |
Cycle |
|
psCMVtk (1.0) + GCV (12.5) depending on tumor accessible surface or volume |
Min: 0.5 Max: 2.0 |
Intra-/peri-tumoral |
1, 2, 3, 4, 5, 7, 9, 11, 13, 15 |
10 rounds or until limiting toxicity or progression |
|
psCMVhIL-2 (0.5) + psCMVhGM-CSF (0.5) + allogeneic tumor extract |
1.0 |
Sub-cutaneous vaccine |
1, 2, 3, 4, 5, 7, 9, 11, 13, 15 |
10 rounds or until limiting toxicity or progression |
#Patients start with a minimum 0.5 ml (weeks 1 and 2). Starting the 3rd week, the maximal doses (according the tumor burden) are applied. Follow-up until week 30.
*Each vaccine containing 0.5 mg psCMVhIL-2 + 0.5 mg psCMVhGM-CSF + 0.25 ml formolized allogenic tumor extracts.