Table 6.
Summary of Phase I IL1/Chemo Clinical Trials
| Study/pts | Chemo | IL1 doses | Schedules | Heme effect | Tox |
|---|---|---|---|---|---|
| Crown 1991 | 5FU | 0.002–0.1 μg/kg | IL1 alone | Plts OK | Hypotension |
| N=19 | 833 mg/m2 | 5FU alone | Marrow- | Pain | |
| GI malig | Daily×3 | IL1+5FU | No change; higher nadir; dec G-penia duration | ||
| Nemunaitis 1994 | Bu/CY/TBI | 0.01 μg/kg | D1–D5 | 25 D to ANC | Fever/chills |
| N=17 | or Bu/Cy | 0.02 μg/kg | >500 | Hypotension | |
| AML | 0.05 μg/kg | 12% infection | 30% fluids, | ||
| ABMT | Vasopressors | ||||
| Smith 1993 | Carboplatin | 0.03 μg/kg | D−5—D−1 | Prenadir 19k | Hypotension |
| N=43 | 800 mg/m2 | 0.1 μg/kg | D1–D5 | Plts | 2-pressors |
| Solid T | 0.03 μg/kg | D1–D5 | Postnadir | Pain | |
| 91K–332K | Capillary leak | ||||
| (0.3 μg dose) | |||||
| Schuchter 1994 | Cyclophos | 0.03 μg/kg | D−5—D−1 | ANC nadir | Hypotension |
| N=43 | 1.5 mg/m2 | 0.06 μg/kg | D−2—D2 | >500, dose | 2-pressors |
| Solid T | 0.1 μg/kg | D1–D5 | level 1 & 2 | Pain | |
| Schd A, B; | Capillary leak | ||||
| Schd C | |||||
| ANC<200 |
5FU, 5 fluorouracil; Plts, platelets; G-penia, granulocytopenia; AML, acute myeloid leukemia; ABMT, autologous bone marrow transplant; Bu/Cy, busulfan, cytclophosphamide; TBI, total body irradiation; D, day; Schd, schedule.