Toxicities requiring dose modifications by patient cohort
| Cohort and d of IL-12 administration . | Initial dose . | Dose modified/IL-12 discontinued . | Toxicity (no. of patients) . | Median no. of IL-12 doses/patient (range) . |
|---|---|---|---|---|
| Cohort 1: d 29 | 30 ng/kg | 1/6 | ITP (1) | 29 (25-45) |
| Cohort 2: d 16 | 30 ng/kg | 0/6 | 40 (12-49) | |
| Cohort 3: d 16 | 100 ng/kg | 0/9 | Pleural effusion (1) | 48 (4-54) |
| Cohort 4: d 16 | 300 ng/kg | 3/9 | Hemolytic anemia- (1), fever (2), increased LFTs (2), fatigue (1) | 36 (2-49) |
| Cohort 5: d 16 | 500 ng/kg | 3/3 | Increased LFTs (DLT) (2), fever (3), myalgia (1) | 12 (8-51) |
| Cohort 6: d 2 | 300 ng/kg | 2/6 | Increased LFTs (2), fever (2), sweating (2), neutropenia (1), cachexia (1) | 38 (24-52) |
| Cohort 7: d 2 | 500 ng/kg | 4/4 | Increased LFTs (DLT) (2), nausea (DLT) (1) | 2 (2-43) |
| Cohort and d of IL-12 administration . | Initial dose . | Dose modified/IL-12 discontinued . | Toxicity (no. of patients) . | Median no. of IL-12 doses/patient (range) . |
|---|---|---|---|---|
| Cohort 1: d 29 | 30 ng/kg | 1/6 | ITP (1) | 29 (25-45) |
| Cohort 2: d 16 | 30 ng/kg | 0/6 | 40 (12-49) | |
| Cohort 3: d 16 | 100 ng/kg | 0/9 | Pleural effusion (1) | 48 (4-54) |
| Cohort 4: d 16 | 300 ng/kg | 3/9 | Hemolytic anemia- (1), fever (2), increased LFTs (2), fatigue (1) | 36 (2-49) |
| Cohort 5: d 16 | 500 ng/kg | 3/3 | Increased LFTs (DLT) (2), fever (3), myalgia (1) | 12 (8-51) |
| Cohort 6: d 2 | 300 ng/kg | 2/6 | Increased LFTs (2), fever (2), sweating (2), neutropenia (1), cachexia (1) | 38 (24-52) |
| Cohort 7: d 2 | 500 ng/kg | 4/4 | Increased LFTs (DLT) (2), nausea (DLT) (1) | 2 (2-43) |
ITP indicates immune thrombocytopenic purpura.