Intravesical therapy with pertussis toxin before radical cystectomy in patients with bladder cancer: a Phase I study.
OBJECTIVE
To ascertain the side effects of intravesical instillation of pertussis toxin (PTX) because it inhibits tumor cell motility in vitro and in vivo and seems to be a promising therapeutic approach against cancer.


METHODS
We initiated a Phase I study and measured the effect of intravesical instillation of PTX before radical cystectomy. Study end points were PTX-related side effects. PTX was instilled at five dose levels, starting with 14 microg and continuing to 72 microg.


RESULTS
Fifteen patients, with a median age of 64 years, were included in the study. Intravesical instillation of PTX was without local or systemic side effects (grade 0, according to National Cancer Institute toxicity criteria).


CONCLUSIONS
Treatment with PTX was safe and well tolerated without any significant local or systemic toxicity in dosages up to 72 microg. Therefore, the influence of PTX on local tumor should be evaluated in a Phase II study.
Otto
T
T
Department of Urology, University of Essen Medical School, Germany.
Lümmen
G
G
Kälble
T
T
Recker
F
F
Krege
S
S
Bex
A
A
Noll
F
F
Rübben
H
H
D000283:Administration, Intravesical; D000368:Aged; D002295:Carcinoma, Transitional Cell / Q000601:surgery / Q000628:therapy*; D015653:Cystectomy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D037342:Pertussis Toxin; D011300:Preoperative Care; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000601:surgery / Q000628:therapy*; D010566:Virulence Factors, Bordetella / Q000008:administration & dosage*
D010566:Virulence Factors, Bordetella; D037342:Pertussis Toxin