Main patient characteristics
| Patient (CIP) . | Disease status* . | AJCC staging . | Clinical outcome* . | Prior treatments . | Infusions† . | Total GMLs infused, ×107 . | Vector used . |
|---|---|---|---|---|---|---|---|
| CIP-5 | PD | M1b | SD (50 mo) | Chemotherapy (CVD), surgery, biochemotherapy (IFNα2b, IL2, CVD) | 5 + 10 | 69,5 | LM3TN/M3-CSM |
| CIP-6 | PD | M1c | PD | Adjuvant therapy (IFNα2b), biochemotherapy (IFNα2b, IL2, CVD) | 5 | 19,5 | LM3TN |
| CIP-11 | PD | M1c | PD | Surgery, chemotherapy (DTIC) | 5 + 3 | 34,5 | LM3TN |
| CIP-13 | PD | M1c | PD | Adjuvant therapy (IFNα2b), chemotherapy (DTIC, CVD) | 5 | 19,5 | LM3TN |
| CIP-18 | PD | M1b | PD | Adjuvant therapy (IFNα2b) | 5 + 3 | 34,5 | M3-CSM |
| CIP-19 | NED | NED | NED (61 mo+) | Biochemotherapy (IFNα2b, IL2, CVD), surgery, biotherapy (IFNα2b and IL2) | 5 + 9 | 64,5 | M3-CSM |
| CIP-21 | PD | M1c | PD | Surgery, polichemotherapy with CDDP+DTIC | 5 | 19,5 | LM3TN |
| CIP-23 | PD | M1c | PD | Surgery, biochemotherapy (DTIC and IFNα2b), vaccination with pulsed DCs, biochemotherapy (fotemustine, IFNα2b and IL2), surgery | 5 | 19,5 | LM3TN |
| CIP-25 | PD | M1b | PD | Biochemotherapy (DTIC, CDDP +IFNα2b), immunotherapy (idiotype mAb + low doses IL2), radiotherapy + DTIC, mochemotherapy (taxanes) | 5 + 4 | 39,5 | LM3TN |
| CIP-26 | PD | IIIc | CR (6 + 3 mo) | Surgery, ILP, biotherapy (IFNα2b and IL2), ILP, surgery | 5 + 6 | 49,5 | LM3TN |
| Patient (CIP) . | Disease status* . | AJCC staging . | Clinical outcome* . | Prior treatments . | Infusions† . | Total GMLs infused, ×107 . | Vector used . |
|---|---|---|---|---|---|---|---|
| CIP-5 | PD | M1b | SD (50 mo) | Chemotherapy (CVD), surgery, biochemotherapy (IFNα2b, IL2, CVD) | 5 + 10 | 69,5 | LM3TN/M3-CSM |
| CIP-6 | PD | M1c | PD | Adjuvant therapy (IFNα2b), biochemotherapy (IFNα2b, IL2, CVD) | 5 | 19,5 | LM3TN |
| CIP-11 | PD | M1c | PD | Surgery, chemotherapy (DTIC) | 5 + 3 | 34,5 | LM3TN |
| CIP-13 | PD | M1c | PD | Adjuvant therapy (IFNα2b), chemotherapy (DTIC, CVD) | 5 | 19,5 | LM3TN |
| CIP-18 | PD | M1b | PD | Adjuvant therapy (IFNα2b) | 5 + 3 | 34,5 | M3-CSM |
| CIP-19 | NED | NED | NED (61 mo+) | Biochemotherapy (IFNα2b, IL2, CVD), surgery, biotherapy (IFNα2b and IL2) | 5 + 9 | 64,5 | M3-CSM |
| CIP-21 | PD | M1c | PD | Surgery, polichemotherapy with CDDP+DTIC | 5 | 19,5 | LM3TN |
| CIP-23 | PD | M1c | PD | Surgery, biochemotherapy (DTIC and IFNα2b), vaccination with pulsed DCs, biochemotherapy (fotemustine, IFNα2b and IL2), surgery | 5 | 19,5 | LM3TN |
| CIP-25 | PD | M1b | PD | Biochemotherapy (DTIC, CDDP +IFNα2b), immunotherapy (idiotype mAb + low doses IL2), radiotherapy + DTIC, mochemotherapy (taxanes) | 5 + 4 | 39,5 | LM3TN |
| CIP-26 | PD | IIIc | CR (6 + 3 mo) | Surgery, ILP, biotherapy (IFNα2b and IL2), ILP, surgery | 5 + 6 | 49,5 | LM3TN |
MAGE-A3 expression was evaluated by RT-PCR analysis on a tumor biopsy or surgical specimen. Bold text in table body indicates responding patients.
CIP indicates cancer immunotherapy patient; CVD: CDDP, vinblastin, and DTIC; ILP, isolated limb perfusion; PD, progressive disease; SD, stable disease; NED, no evidence of disease; and CR, complete response.
Disease status at study entry and clinical outcome.
Five administrations of escalating doses of GML (first cycle of treatment) plus additional infusions performed in some patients.