title: A phase I study of intravesical continuous perfusion of recombinant interleukin-2 in patients with superficial bladder cancer.
abstract: A Phase I study was started to evaluate the locoregional and/or systemic toxic effects of the continuous perfusion of recombinant interleukin-2 (rIL-2) in superficial bladder cancer. Three different dose levels were used: 3 x 10(6) IU/day (3 patients), 9 x 10(6) IU/day (3 patients) and 27 x 10(6) IU/day (3 patients). Two patients (one treated with 3 x 10(6) and another with 27 x 10(6) IU/day of rIL-2) had hematuria after the end of the treatment, one patient had fever (grade I) and 7 of 9 patients experienced hypotension (grade I-II). All effects were not dose related. Routine laboratory tests indicated that no significant variations of biochemical parameters occurred. A phenotypic analysis of white blood cells detectable in the bladder, showed an evident locoregional activation of lymphoid cells. In particular, T lymphocytes expressed activation antigens (such as CD25 and HLA-DR) following treatment with rIL-2. A 6- to 12-month clinical follow-up, showed that all patients but one (which recurred after 5 months) are alive and disease-free. This therefore indicates that the locoregional perfusion of rIL-2 is safe and gives clinical results similar to those obtained using Calmette-Guérin bacillus locoregional instillation, in patients who underwent a transurethral resection of superficial bladder cancer.
authors.affiliation: Sezione Decentrata di Tecnologie Biomediche, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Ferlazzo
authors.forename: C
authors.initials: C
authors.lastname: Magno
authors.forename: G
authors.initials: G
authors.lastname: Lupo
authors.forename: M
authors.initials: M
authors.lastname: Rizzo
authors.forename: R
authors.initials: R
authors.lastname: Iemmo
authors.forename: C
authors.initials: C
authors.lastname: Semino
authors.forename: G
authors.initials: G
authors.lastname: Melioli
mesh_terms: D000283:Administration, Intravesical; D000368:Aged; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006684:HLA-DR Antigens / Q000032:analysis; D006417:Hematuria / Q000139:chemically induced; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D015375:Receptors, Interleukin-2 / Q000032:analysis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D001749:Urinary Bladder Neoplasms / Q000276:immunology / Q000628:therapy* / Q000652:urine; D014556:Urine / Q000166:cytology
chemical_list: D006684:HLA-DR Antigens; D007376:Interleukin-2; D015375:Receptors, Interleukin-2; D011994:Recombinant Proteins