Table 1.
Clinical profiles of patients and tumors, and summary of the presence of RNA, recombinant HLA-B7, and increase in CD3+ cell infiltration after gene transfer
| Patient no. | Patient I.D. | Age/ Sex | HLA haplotype | Previous treatment | Site | DNA dose, μg (group) | RNA* | HLA-B7† | CD3+ infil- tration |
|---|---|---|---|---|---|---|---|---|---|
| 1 | G.M. | 50/M | A2, 19; B35−, w6; C4,−; DR1, 12, 52; DQ1, 3, 7 | BCG; chemotherapy; IL-2; TIL; limb perfusion with melphalan, tumor necrosis factor, and interferonγ | Left thigh | 3(I), 30(II), 100(III) | + | ++ | +++ |
| 2 | A.P. | 46/F | A1, 3; B8, 27, w6, w4; C2, 7; DR13, 15 | Surgery, radiation, chemotherapy, activated primed T cells, and IL-2 | Right lateral thigh, right gluteal, right shoulder | 3(I), 30(II) | + | ind. | +++ |
| 3 | A.H. | 54/M | A1, 2; B8, w6; C7; DR1, 15; DQ1, 6, 51 | Surgery, chemotherapy, and IL-2 | Left chest | 3 | − | + | ++ |
| 4 | I.M. | 72/F | A2, 29; B8, −, w6; DR3, −, 52 | Surgery | Left knee | 30 | + | + | ND |
| 5 | G.L. | 40/F | A11, 30; B13, 44, w4, w6; C3, 6; DR2, 7, 53; DQ1, 2, 5, 51 | Surgery, and limb perfusion with tumor necrosis factor and interferon α | Right thigh | 100 | + | ind. | − |
| 6 | D.M. | 52/F | A2, −; B13, −, w4; C6, −; DR7, 8, 53; DQ2, 4 | Surgery and interferon | Scalp | 100 | + | +/− | ND |
| 7 | F.B. | 68/F | A23, 24; B13, 44, w4, w6; C4, −; DR7, −, 53; DQ2, 3 | Surgery and radiation | Left back | 100 | + | ++ | + |
| 8 | M.S. | 45/F | A3, 29; B44, 60; DR7, 13, 52, 53; DQ1, 2 | Surgery | Right thigh | 300 | ND | +/− | ++ |
| 9 | G.B. | 29/M | A3, 26; B18, 62, w6; C3, 5; DQ2; DR52, 53 | Surgery and radiation | Right neck | 300 | + | +/− | ++ |
| 10 | J.C. | 34/M | A1, 11; B44, −, w4; C5, −; DR1, 7, 53 | Surgery, cisplatinum therapy, radiation, Dartmouth regimen, and chemotherapy | Left chest wall | 300 | − | ND | ND |
I.D., Identification; M, male; F, female; BCG, Bacille Calmette–Guérin; ND, not determined; ind., indeterminate.
RNA was detected by reverse transcriptase–PCR.
HLA-B7 was detected by immunostaining.