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  • Title: 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.
    Author: Schreinemachers LM, van der Meijden AP, Wagenaar J, Steerenberg PA, Feitz WF, Groothuis DG, Tiesjema RH, de Jong WH, Debruyne FM, Ruitenberg EJ.
    Journal: Eur Urol; 1988; 14(1):15-21. PubMed ID: 2963745.
    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.
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