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.
|
| Abstract |
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.
|
|---|---|
| Authors | L M Schreinemachers, A P van der Meijden, J Wagenaar, P A Steerenberg, W F Feitz, D G Groothuis, R H Tiesjema, W H de Jong, F M Debruyne, E J Ruitenberg |
| Journal | European urology (Eur Urol) Vol. 14 Issue 1 Pg. 15-21 ( 1988) ISSN: 0302-2838 [Print] Switzerland |
| PMID | 2963745 (Publication Type: Journal Article) |
| Chemical References |
|
| Topics |
|
Join CureHunter, for free Research Interface BASIC access!
Realize the full power of the drug-disease research graph!