Clinical and immunological responses
Lptn dose level . | Patient . | No. injections . | Local inflammatory reaction* . | Systemic immune response . | Tumor response, WHO 1979 . | Additional therapy after relapse . | Response to additional therapy . | Time to relapse, d . | Outcome . | Survival from first injection, d . | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ab . | NK . | Cytokine . | Week 8 . | Week 24 . | |||||||||
1 | 1 | 5 | + | Yes | No | NE | PD | NE | None | — | 50 | DOD | 95 |
1 | 2 | 7 | + | No | Yes | NE | SD | NE | Oral VP16 | PR | 142 | DOD | 730 |
1 | 3 | 5 | + | Yes | No | NE | SD | NE | None | — | 70 | DOD | 313 |
2 | 4 | 4 | + | Yes | No | NE | PD | NE | Multiagent chemotherapy | PR | 166 | DOD | 971 |
2 | 5 | 8 | +++ | Yes | No | NE | CR | PD | None | — | 49 | DOD | 818 |
2 | 6 | 4 | + | No | No | NE | PD | NE | None | — | 53 | DOD | 117 |
3 | 7 | 2 | + | Not evaluable because of rapid progression after first injection | DOD | 11 | |||||||
3 | 8 | 2 | +++ | Not evaluable because of rapid progression after first injection | DOD | 22 | |||||||
3 | 9 | 2 | + | Not evaluable because of rapid progression after first injection | DOD | 28 | |||||||
3 | 10 | 8 | +++ | Yes | Yes | — | SD | PD | None | — | 185 | DOD | 257 |
3 | 11 | 8 | ++ | Yes | Yes | IL-4, IL-5, IL-10 | VGPR | PD | CYCHE | — | 173 | DOD | 512 |
3 | 12 | 4 | ++ | Not evaluable because of rapid progression after first injection | DOD | 47 | |||||||
3 | 13 | 4 | + | Yes | Yes | IL-4, IL-5, IL-10 | PD | NE | Oral VP16 | — | 41 | DOD | 308 |
3 | 14 | 4 | ++ | Yes | Yes | — | PD | NE | Oral VP16/CYCHE | MR | 42 | DOD | 530 |
3 | 15 | 4 | + | Yes | No | — | PD | NE | None | — | 35 | DOD | 60 |
4 | 16 | 4 | + | Yes | No | IL-4, IL-5, IL-10 | PD | NE | Oral VP16 | — | 84 | DOD | 180 |
4 | 17 | 8 | ++ | Yes | No | IL-4, IL-5, IL-10 | SD | SD | CYCHE | PD | 276 | AWD | 631+ |
4 | 18 | 4 | 0 | Yes | No | — | PD | NE | None | — | 106 | DOD | 143 |
4 | 19 | 5 | +++ | Yes | No | IL-4, IL-5, IL-10 | PD | NE | None | 2nd tumor | 59 | DOD | 183 |
4 | 20 | 8 | ++ | Yes | Yes | IL-4, IL-5 | CR | CR | Off all therapy | — | — | NED | 695+ |
4 | 21 | 8 | +++ | Yes | No | IL-4, IL-5, IL-10 | SD | SD | CYCHE | SD | — | DOD | 507 |
Lptn dose level . | Patient . | No. injections . | Local inflammatory reaction* . | Systemic immune response . | Tumor response, WHO 1979 . | Additional therapy after relapse . | Response to additional therapy . | Time to relapse, d . | Outcome . | Survival from first injection, d . | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ab . | NK . | Cytokine . | Week 8 . | Week 24 . | |||||||||
1 | 1 | 5 | + | Yes | No | NE | PD | NE | None | — | 50 | DOD | 95 |
1 | 2 | 7 | + | No | Yes | NE | SD | NE | Oral VP16 | PR | 142 | DOD | 730 |
1 | 3 | 5 | + | Yes | No | NE | SD | NE | None | — | 70 | DOD | 313 |
2 | 4 | 4 | + | Yes | No | NE | PD | NE | Multiagent chemotherapy | PR | 166 | DOD | 971 |
2 | 5 | 8 | +++ | Yes | No | NE | CR | PD | None | — | 49 | DOD | 818 |
2 | 6 | 4 | + | No | No | NE | PD | NE | None | — | 53 | DOD | 117 |
3 | 7 | 2 | + | Not evaluable because of rapid progression after first injection | DOD | 11 | |||||||
3 | 8 | 2 | +++ | Not evaluable because of rapid progression after first injection | DOD | 22 | |||||||
3 | 9 | 2 | + | Not evaluable because of rapid progression after first injection | DOD | 28 | |||||||
3 | 10 | 8 | +++ | Yes | Yes | — | SD | PD | None | — | 185 | DOD | 257 |
3 | 11 | 8 | ++ | Yes | Yes | IL-4, IL-5, IL-10 | VGPR | PD | CYCHE | — | 173 | DOD | 512 |
3 | 12 | 4 | ++ | Not evaluable because of rapid progression after first injection | DOD | 47 | |||||||
3 | 13 | 4 | + | Yes | Yes | IL-4, IL-5, IL-10 | PD | NE | Oral VP16 | — | 41 | DOD | 308 |
3 | 14 | 4 | ++ | Yes | Yes | — | PD | NE | Oral VP16/CYCHE | MR | 42 | DOD | 530 |
3 | 15 | 4 | + | Yes | No | — | PD | NE | None | — | 35 | DOD | 60 |
4 | 16 | 4 | + | Yes | No | IL-4, IL-5, IL-10 | PD | NE | Oral VP16 | — | 84 | DOD | 180 |
4 | 17 | 8 | ++ | Yes | No | IL-4, IL-5, IL-10 | SD | SD | CYCHE | PD | 276 | AWD | 631+ |
4 | 18 | 4 | 0 | Yes | No | — | PD | NE | None | — | 106 | DOD | 143 |
4 | 19 | 5 | +++ | Yes | No | IL-4, IL-5, IL-10 | PD | NE | None | 2nd tumor | 59 | DOD | 183 |
4 | 20 | 8 | ++ | Yes | Yes | IL-4, IL-5 | CR | CR | Off all therapy | — | — | NED | 695+ |
4 | 21 | 8 | +++ | Yes | No | IL-4, IL-5, IL-10 | SD | SD | CYCHE | SD | — | DOD | 507 |
Clinical status of patients was updated September 2002.
IL-4, IL-5, and IL-10 denote cytokine secretion by PBMCs restimulated by the immunizing cell line, JF.
Ab indicates antibody against the immunizing cells; VP, etoposide; CYCHE, autologous vaccine; MR, mixed response; DOD, died of disease; AWD, alive with disease; NED, no evidence of disease; NE, not evaluable; PD, progressive disease; SD, stable disease; CR, complete response; PR, partial response.
Diameter of erythema at the site of injection: 0, none; 1 cm < + ≤ 3 cm; 3 cm < ++ ≤ 8 cm; +++ > 8 cm.