Intravesical and intradermal Bacillus Calmette-Guérin application. A phase I study to the toxicity of a Dutch Bacillus Calmette-Guérin preparation in patients with superficial bladder cancer.
In 30 patients toxic side effects of Bacillus Calmette-Guérin (BCG) were evaluated after intradermal and intravesical administration. The BCG preparation (BCG-RIVM) was produced in a homogeneously dispersed culture yielding a relatively high number of culturable particles per milligram dry weight BCG. All patients had a history of recurrent multiple noninvasive superficial transitional cell carcinoma of the bladder, and were previously unsuccessfully treated with intravesical chemotherapy (epodyl and/or adriamycin). BCG-RIVM (1 X 10(9) culturable particles) was instilled in the bladder, in combination with intradermal BCG-RIVM (8 X 10(7) culturable particles) administration once a week for 6 consecutive weeks. BCG was applied intradermally by a multiple-puncture technique. During and after therapy, subjective and objective side effects and toxicity were registered. Hematology and blood chemistry, including hepatic and renal function, was monitored. Only minor toxicity and/or side effects were observed during therapy and for a period of 6 months after treatment. After a period of 7 days no significant amount of BCG bacteria could be detected in the urine of 24 investigated patients.
D000283:Administration, Intravesical; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use / Q000633:toxicity*; D002295:Carcinoma, Transitional Cell / Q000628:therapy*; D003875:Drug Eruptions / Q000209:etiology; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
D001500:BCG Vaccine