Premium
A phase I study of an outpatient regimen of recombinant human interleukin‐2 and alpha‐2a‐interferon in patients with solid tumors
Author(s) -
Huberman M.,
Bering H.,
Fallon B.,
Tessitore J.,
Sonnenborn H.,
Paul S.,
Zeffren J.,
Levitt D.,
Groopman J.
Publication year - 1991
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19911015)68:8<1708::aid-cncr2820680810>3.0.co;2-v
Subject(s) - medicine , regimen , recombinant dna , alpha interferon , outpatient clinic , interferon , gastroenterology , pharmacology , immunology , biochemistry , chemistry , gene
This study was undertaken to define the maximum tolerated dose (MTD) of recombinant interleukin‐2 (IL‐2) that could be combined with a fixed dose of alpha‐2a‐interferon (α‐IFN) in an outpatient setting. The schedule called for IL‐2 to be given by a 2‐hour intravenous infusion 5 days a week for 4 weeks. The α‐IFN was given at a dose of 6 × 10 6 U/m 2 /d intramuscularly 3 days per week (Monday, Wednesday, and Friday). The IL‐2 dose was escalated in four dose levels from 1 to 4 × 10 6 U/m 2 /d. The MTD in this study of 17 patients was at the fourth dose level of IL‐2 (4 × 10 6 U/m 2 /d). In addition to the usual IL‐2 toxicities, debilitating fatigue limited outpatient administration of this dose. Although the response rate was low, with partial responses seen in only 1 of 15 patients, 2 of 5 patients with melanoma treated at the higher dose levels had objective tumor shrinkage with one partial and one minor response. Thus, an IL‐2 dose of 3 × 10 6 U/m 2 /d combined with a recombinant α‐2a‐IFN dose of 6 × 10 6 U/m 2 /d is recommended for Phase II studies.