E. Bouffet et al., PILOT-STUDY OF IMMUNOTHERAPY USING INTERLEUKIN-2 IN CHILDREN WITH SOLID TUMORS OR LYMPHOMAS, International journal of pediatric hematology/oncology, 2(6), 1995, pp. 489-493
Purpose: A pilot study using recombinant interleukin 2 (rIL-2) was und
ertaken to assess the efficacy of this cytokine in children with advan
ced cancers. Patients and Methods: Twelve assessable patients entered
the study. They were treated either by continuous infusion (four patie
nts) or by bolus-type infusion (eight patients). Treatment consisted o
f one to two cycles of rIL-2, at a dose of 18 x 10(6) IU/m(2)/day (con
tinuous infusion) or 18 x 10(6) IU/m(2)/8 hours (bolus schedule) for 5
days, followed by a 6-day rest. The same dose of rIL-2 was infused ag
ain for 4 1/2 days starting on day 12. Patients with no evidence of pr
ogression received an identical second course of treatment after a 3-w
eek rest. Results: A minor response was achieved in one patient. All o
ther patients had stable or progressive disease after one (nine patien
ts) or two cycles (two patients). Toxicity was mainly renal and cardio
vascular, leading to dose modifications in 10 of 12 patients. Conclusi
ons: This phase I/II study shows that minimal antitumor activity is ob
tained by isolated rIL-2 treatment in end-stage disease. Based on expe
rimental models, the authors suggest that the rIL-2 therapy may be eff
ective only if instituted earlier in the course of the disease and/or
is associated with alternative treatments.