A phase I study of intravesical continuous perfusion of recombinant interleukin-2 in patients with superficial bladder cancer

• Published in: American journal of clinical oncology Vol. 18; no. 2; p. 100
• Main Authors: Ferlazzo, G, Magno, C, Lupo, G, Rizzo, M, Iemmo, R, Semino, C, Melioli, G
• Format: Journal Article
• Language: English
• Published: United States 01-04-1995
• Subjects: Administration, Intravesical; Aged; Disease-Free Survival; Drug Administration Schedule; Follow-Up Studies; Hematuria - chemically induced; HLA-DR Antigens - analysis; Humans; Hypotension - chemically induced; Interleukin-2 - administration & dosage; Interleukin-2 - adverse effects; Leukocyte Count - drug effects; Male; Middle Aged; Neoplasm Recurrence, Local; Receptors, Interleukin-2 - analysis; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; T-Lymphocytes - drug effects; T-Lymphocytes - immunology; Urinary Bladder Neoplasms - immunology; Urinary Bladder Neoplasms - therapy; Urinary Bladder Neoplasms - urine; Urine - cytology
• ISSN: 0277-3732
• DOI: 10.1097/00000421-199504000-00002

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.