title: Phase II evaluation of interleukin-4 in patients with non-Hodgkin's lymphoma: a Southwest Oncology Group trial.
abstract: We performed a phase II, Southwest Oncology Group (SWOG) clinical trial of recombinant human interleukin-4 (rhuIL-4) in patients with previously treated non-Hodgkin's lymphoma (NHL). We studied 18 eligible patients with low-grade and 21 patients with intermediate- or high-grade NHL. All patients had received prior chemotherapy. A protocol amendment after the first four patients reduced the frequency of s.c. rhuIL-4 administration from daily to 3 times per week at 3 microg/kg and limited the number of prior chemotherapy regimens allowed. We documented no complete or partial responses in the low-grade NHL group [0%; 95% confidence interval (CI) 0-19%]. One patient in the intermediate/high-grade NHL group developed a partial response lasting longer than 15 months (5%; 95% CI 0-24%). Median survivals for the low- and intermediate/high-grade NHL groups were 15 and 13 months, respectively. Common toxicities included: arhralgia/myalgia, fatigue/malaise/lethargy, fever, headache, nausea and rigors/chills. Cardiac toxicity, gastrointestinal ulceration and nasal congestion due to rhuIL-4 were not prominent toxicities in our patients. Our previously treated NHL patients tolerated s.c. rhuIL-4 at a dose of 3 microg/kg given 3 times per week, but objective response rarely occurred. Further evaluation of rhuIL-4 in these patient populations does not appear warranted.
authors.affiliation: Arizona Cancer Center, Tucson 85724-0001, USA. ctaylor@azcc.arizona.edu
authors.forename: C W
authors.initials: CW
authors.lastname: Taylor
authors.forename: M
authors.initials: M
authors.lastname: LeBlanc
authors.forename: R I
authors.initials: RI
authors.lastname: Fisher
authors.forename: D F
authors.initials: DF
authors.lastname: Moore
authors.forename: R W
authors.initials: RW
authors.lastname: Roach
authors.forename: L
authors.initials: L
authors.lastname: Elias
authors.forename: T P
authors.initials: TP
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015847:Interleukin-4 / Q000009:adverse effects / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D011994:Recombinant Proteins; D015847:Interleukin-4