DMF5 patient cell treatment characteristics
| Patient no. . | Age, y/sex . | Prior treatment* . | Sites of disease† . | No. of cells × 109 . | Percentage CD4/8 . | Percentage Tet . | Percentage IC IFN-γ‡ . | ELISPOT . | Doses IL-2 . | Toxicity¶ (skin/eye/ear) . | Tumor response, mo** . | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IL-2§ . | IFN-γ‖ . | |||||||||||
| 1 | 36/F | R,S,I | bo, li, lu | 22.2 | 17/83 | 73 | 52 | 95 | 173 | 10 | 1/2/3 | NR |
| 2 | 43/F | S,I | lu | 10.5 | 15/85 | 46 | 37 | 37 | 166 | 5 | 2/2/3 | PR (17+) |
| 3 | 60/F | S,I | bo, ln, sc | 6.5 | 7/93 | 56 | 40 | 1 | 56 | 3 | 0/0/0 | NR |
| 4 | 38/M | S,C,I | eye, sc | 12.0 | 22/78 | 65 | 38 | 24 | > 112 | 8 | 2/2/1 | NR |
| 5 | 47/F | R,S,I | sc, cu | 23.3 | 37/63 | 61 | 21 | 91 | 53 | 5 | 1,1††/2,2††/0,3†† | PR (17+) |
| 6 | 57/M | R,S,C,I | ln, bo, sc, lu | 17.6 | 27/73 | 69 | 29 | 38 | 52 | 7 | 1/0/0 | NR |
| 7 | 33/M | S,I | ln, li, lu | 1.5 | 11/89 | 33 | 19 | 68 | 132 | 10 | 1/0/0 | NR |
| 8 | 46/M | S,I | ln, br, lu | 5.7 | 32/68 | 49 | 17 | 26 | 65 | 7 | 0/2/0 | PR (16+) |
| 9 | 54/M | S,I | ln, sp, sc | 3.8 | 28/72 | 69 | 28 | 860 | 164 | 5 | 1/0/0 | PR (9) |
| 10 | 35/M | R,S,I | ln, lu, sc | 2.0 | 61/39 | 48 | 7 | 1200 | 32 | 11 | 1/2/0 | NR |
| 11 | 60/F | R,S,I | br, sc, lu | 3.0 | 27/73 | 60 | 19 | 310 | 152 | 15 | 1/0/0 | NR |
| 12 | 49/F | S,I | ln, ki, li, lu, sp | 4.8 | 2/98 | 85 | 61 | 66 | 34 | 4 | 0/0/0 | NR |
| 13 | 54/M | R,S,I | In, sc | 38.0 | 6/94 | 91 | 70 | 2250 | > 292 | 9 | 0/2/3 | PR (4) |
| 14 | 24/F | R,S,I | ln, sc | 80.0 | 10/90 | 75 | 64 | 4767 | > 349 | 6 | 1/1/3 | NR |
| 15 | 56/M | R,S,I | ip, li, lu | 30.5 | 13/87 | 95 | 72 | 990 | > 191 | 9 | 1/1/1 | NR |
| 16 | 54/M | S,C,I | ln, sc | 29.1 | 4/96 | 89 | 54 | > 270 | > 253 | 7 | 0/0/0 | NR |
| 17 | 37/M | S,I | adr, ln, lar, sc | 9.9 | 2/98 | 77 | 50 | 83 | 27 | 10 | 0/0/0 | NR |
| 18 | 56/F | S,I | ln, sc | 48.2 | 21/79 | 92 | 68 | 1410 | > 157 | 3 | 1/2/3 | PR (3) |
| 19 | 31/F | R,S,C,I | br, sc | 73.7 | 13/60 | 92 | ND | 166 | > 332 | 8 | 2/2/3 | NR |
| 20 | 56/M | S,C,I | adr, ln, lu, im, panc | 107.0 | 33/66 | 91 | ND | 1500 | > 376 | 11 | 1/0/3 | NR |
| Patient no. . | Age, y/sex . | Prior treatment* . | Sites of disease† . | No. of cells × 109 . | Percentage CD4/8 . | Percentage Tet . | Percentage IC IFN-γ‡ . | ELISPOT . | Doses IL-2 . | Toxicity¶ (skin/eye/ear) . | Tumor response, mo** . | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IL-2§ . | IFN-γ‖ . | |||||||||||
| 1 | 36/F | R,S,I | bo, li, lu | 22.2 | 17/83 | 73 | 52 | 95 | 173 | 10 | 1/2/3 | NR |
| 2 | 43/F | S,I | lu | 10.5 | 15/85 | 46 | 37 | 37 | 166 | 5 | 2/2/3 | PR (17+) |
| 3 | 60/F | S,I | bo, ln, sc | 6.5 | 7/93 | 56 | 40 | 1 | 56 | 3 | 0/0/0 | NR |
| 4 | 38/M | S,C,I | eye, sc | 12.0 | 22/78 | 65 | 38 | 24 | > 112 | 8 | 2/2/1 | NR |
| 5 | 47/F | R,S,I | sc, cu | 23.3 | 37/63 | 61 | 21 | 91 | 53 | 5 | 1,1††/2,2††/0,3†† | PR (17+) |
| 6 | 57/M | R,S,C,I | ln, bo, sc, lu | 17.6 | 27/73 | 69 | 29 | 38 | 52 | 7 | 1/0/0 | NR |
| 7 | 33/M | S,I | ln, li, lu | 1.5 | 11/89 | 33 | 19 | 68 | 132 | 10 | 1/0/0 | NR |
| 8 | 46/M | S,I | ln, br, lu | 5.7 | 32/68 | 49 | 17 | 26 | 65 | 7 | 0/2/0 | PR (16+) |
| 9 | 54/M | S,I | ln, sp, sc | 3.8 | 28/72 | 69 | 28 | 860 | 164 | 5 | 1/0/0 | PR (9) |
| 10 | 35/M | R,S,I | ln, lu, sc | 2.0 | 61/39 | 48 | 7 | 1200 | 32 | 11 | 1/2/0 | NR |
| 11 | 60/F | R,S,I | br, sc, lu | 3.0 | 27/73 | 60 | 19 | 310 | 152 | 15 | 1/0/0 | NR |
| 12 | 49/F | S,I | ln, ki, li, lu, sp | 4.8 | 2/98 | 85 | 61 | 66 | 34 | 4 | 0/0/0 | NR |
| 13 | 54/M | R,S,I | In, sc | 38.0 | 6/94 | 91 | 70 | 2250 | > 292 | 9 | 0/2/3 | PR (4) |
| 14 | 24/F | R,S,I | ln, sc | 80.0 | 10/90 | 75 | 64 | 4767 | > 349 | 6 | 1/1/3 | NR |
| 15 | 56/M | R,S,I | ip, li, lu | 30.5 | 13/87 | 95 | 72 | 990 | > 191 | 9 | 1/1/1 | NR |
| 16 | 54/M | S,C,I | ln, sc | 29.1 | 4/96 | 89 | 54 | > 270 | > 253 | 7 | 0/0/0 | NR |
| 17 | 37/M | S,I | adr, ln, lar, sc | 9.9 | 2/98 | 77 | 50 | 83 | 27 | 10 | 0/0/0 | NR |
| 18 | 56/F | S,I | ln, sc | 48.2 | 21/79 | 92 | 68 | 1410 | > 157 | 3 | 1/2/3 | PR (3) |
| 19 | 31/F | R,S,C,I | br, sc | 73.7 | 13/60 | 92 | ND | 166 | > 332 | 8 | 2/2/3 | NR |
| 20 | 56/M | S,C,I | adr, ln, lu, im, panc | 107.0 | 33/66 | 91 | ND | 1500 | > 376 | 11 | 1/0/3 | NR |
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; sp, spleen; sc, subcutaneous; br, brain; bo, bone; ki, kidney; ip, intraperitoneal; adr, adrenal; lar, larynx; im, intramuscular; and panc, pancreas.
Treatment cell intracellular IFN-γ detected by flow cytometry after 18-hour coculture with mel526+ tumor cells (gated on CD3+).
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).
PR indicates partial responder and NR, nonresponder (all by RECIST criteria); and +, ongoing. Values in parentheses are response duration (in months) after treatment.
Second treatment.