Open label, single arm, exploratory phase I clinical Trial to evaluate efficacy and safety of Mycobacterium w (Mw) in BCG refractory Superficial transitional cell carcinoma

CADILA PHARMACEUTICALS LTD0 个研究点目标入组 22 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Informed Consent obtained & signed:
•o Ability to understand and the willingness to sign a written informed consent document.
•2. Disease characteristics:
•Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ,
•multiple unresected T1 and Ta high grade.
•Performance status-ECOG 0-2
•Life expectancy- -At least 24 weeks
•Haemopoetic values -Absolute neutrophil count greater than or equal to 1,500/mm3, Platelet count greater than or equal to 100,000/mm3, Hemoglobin greater than or equal to 9.0 g/dL

•Patients have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
•Pregnant or nursing women
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, diabetes mellitus unstable angina pectoris, hepatic dysfunctions or with evidence of Cirrhosis cardiac arrythemia, or psychiatric illness/social situations that would limit compliance with study requirements
•History of hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs or any study reagents
•History of splenectomy
•Clinically significant active infection
•Patients who are immuno-compromised
•Patients with eczema

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