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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. 1988

L M Schreinemachers, and A P van der Meijden, and J Wagenaar, and P A Steerenberg, and W F Feitz, and D G Groothuis, and R H Tiesjema, and W H de Jong, and F M Debruyne, and E J Ruitenberg
Department of Urology, Grootziekengasthuis, 's Hertogenbosch, The Netherlands.

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.

UI MeSH Term Description Entries
D007271 Injections, Intradermal The forcing into the skin of liquid medication, nutrient, or other fluid through a hollow needle, piercing the top skin layer. Intradermal Injections,Injection, Intradermal,Intradermal Injection
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009426 Netherlands Country located in EUROPE. It is bordered by the NORTH SEA, BELGIUM, and GERMANY. Constituent areas are Aruba, Curacao, and Sint Maarten, formerly included in the NETHERLANDS ANTILLES. Holland,Kingdom of the Netherlands
D001749 Urinary Bladder Neoplasms Tumors or cancer of the URINARY BLADDER. Bladder Cancer,Bladder Neoplasms,Cancer of Bladder,Bladder Tumors,Cancer of the Bladder,Malignant Tumor of Urinary Bladder,Neoplasms, Bladder,Urinary Bladder Cancer,Bladder Cancers,Bladder Neoplasm,Bladder Tumor,Cancer, Bladder,Cancer, Urinary Bladder,Neoplasm, Bladder,Neoplasm, Urinary Bladder,Tumor, Bladder,Tumors, Bladder,Urinary Bladder Neoplasm
D002295 Carcinoma, Transitional Cell A malignant neoplasm derived from TRANSITIONAL EPITHELIAL CELLS, occurring chiefly in the URINARY BLADDER; URETERS; or RENAL PELVIS. Carcinomas, Transitional Cell,Cell Carcinoma, Transitional,Cell Carcinomas, Transitional,Transitional Cell Carcinoma,Transitional Cell Carcinomas
D003875 Drug Eruptions Adverse cutaneous reactions caused by ingestion, parenteral use, or local application of a drug. These may assume various morphologic patterns and produce various types of lesions. Dermatitis Medicamentosa,Dermatitis, Adverse Drug Reaction,Maculopapular Drug Eruption,Maculopapular Exanthem,Morbilliform Drug Reaction,Morbilliform Exanthem,Drug Eruption,Drug Eruption, Maculopapular,Drug Eruptions, Maculopapular,Drug Reaction, Morbilliform,Drug Reactions, Morbilliform,Eruption, Drug,Eruption, Maculopapular Drug,Eruptions, Drug,Eruptions, Maculopapular Drug,Exanthem, Maculopapular,Exanthem, Morbilliform,Exanthems, Maculopapular,Exanthems, Morbilliform,Maculopapular Drug Eruptions,Maculopapular Exanthems,Morbilliform Drug Reactions,Morbilliform Exanthems,Reaction, Morbilliform Drug,Reactions, Morbilliform Drug
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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