Table 2.
gp100(154) patient cell treatment characteristics
| Patient no. | Age, y/sex | Prior treatment* | Sites of disease† | No. of cells × 109 | Percentage CD4/8 | Percentage Tet | ELISPOT |
Doses IL-2 | Toxicity‖ (skin/eye/ear) | Tumor response, mo¶ | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IL-2‡ | IFN-γ§ | ||||||||||
| 1 | 31/F | S,C,I | ln, ip, li | 3.7 | 35/65 | 60 | 7100 | > 137 | 5 | 1/0/0 | NR |
| 2 | 32/M | S,C,I | ln, im, sc | 10.0 | 36/54 | 78 | 5300 | > 362 | 5 | 2/0/0 | NR |
| 3 | 54/M | S,I | sc | 9.8 | 13/82 | 87 | 2590 | > 302 | 4 | 1/0/0 | NR |
| 4 | 50/M | S,I | ln, gb | 4.6 | 11/78 | 97 | 12 050 | > 409 | 2 | 1/0/0 | NR |
| 5 | 49/F | S,I | ln, lu, sc | 9.9 | 21/80 | 91 | 11 683 | > 451 | 2 | 2/0/0 | NR |
| 6* | 36/F | R,S,C,I | ln, bo, li, sp | 5.8 | 6/89 | 77 | 2370 | > 336 | 5 | 1/0/0 | NR |
| 7 | 60/M | S,I | In, bo, li, lu, sc | 1.8 | 40/56 | 83 | 6117 | > 213 | 4 | 1/0/0 | NR |
| 8 | 50/F | S,C,I | st, li, lu, int, sc | 19.4 | 44/53 | 55 | 2900 | 294 | 5 | 2/2/0 | NR |
| 9 | 25/M | S,I | ln, bo, ip | 2.3 | 44/56 | 84 | ND | 46 | 9 | 0/0/0 | NR |
| 10 | 40/F | S,C,I | br, ln, im | 2.7 | 24/69 | 59 | 6700 | > 445 | 10 | 1/0/0 | NR |
| 11** | 50/M | R,S,C,I | br, ln | 68.8 | 5/96 | 97 | 8167 | > 495 | 8 | 1/2/3 | CR (14+) |
| 12 | 62/M | S,C,I | lu, ln | 46.5 | 20/82 | 85 | 14 583 | > 526 | 7 | 1/2/2 | NR |
| 13** | 44/F | R,S,C,I | li, ln | 54.0 | 2/97 | 90 | 8700 | > 339 | 13 | 1/2/1 | NR |
| 14 | 51/F | S,I | ln, li, lu, sp | 110.0 | 11/88 | 92 | 11 817 | > 421 | 6 | 1/0/2 | PR (4) |
| 15 | 33/M | S,I | ln | 94.1 | 16/78 | 89 | 6833 | > 389 | 6 | 2/0/0 | NR |
| 16 | 41/M | S,I | ln | 39.1 | 18/79 | 90 | 10 967 | > 485 | 7 | 1/0/1 | PR (3) |
ND indicates not done.
R indicates radiation therapy; S, surgery; C, chemotherapy; and I, immunotherapy (high-dose IL-2).
ln indicates lymph node; li, liver; lu, lung; br, brain; sp, spleen; sc, subcutaneous; bo, bone; ki, kidney; ip, intraperitoneal; adr, adrenal; lar, larynx; im, intramuscular; panc, pancreas; st, stomach; int, intestine; gb, gallbladder.
Number of positive IL-2 ELISPOTs per 100 000 infusion PBMCs after 4-hour coculture with mel624+ tumor cells.
Number of positive IFN-γ ELISPOTs per 10 000 infusion PBMCs after 4-hour coculture with mel624+ tumor cells.
Skin toxicity: grade 1, erythema; grade 2, desquamation < 50%; grade 3, desquamation > 50%. Eye toxicity (uveitis): grade 1, asymptomatic; grade 2, anterior, steroid eye drops; grade 3, pan uveitis, surgery. Ear (hearing): grade 1, hearing loss 15 to 25 dB at 2 frequencies; grade 2, > 25 dB at 2 frequencies; grade 3, > 25 dB at 3 frequencies (per CTCAE, Version 3.0).
CR indicates complete responder; PR, partial responder; NR, nonresponder (all by RECIST criteria); and +, ongoing. Values in parentheses are response duration in months after treatment.
Prior treatment with DMF4 TCR.