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. 2014 May 1;34(5):376–384. doi: 10.1089/jir.2013.0010

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.