Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial of Mw in Superficial transitional cell carcinoma to compare the efficacy and toxicity of Mw (intra-dermal) to Intravesical BCG in patients with newly diagnosed Superficial transitional cell carcinoma with high probability of recurrence.

Cadila Pharmaceuticals Ltd0 个研究点目标入组 122 人开始时间: 待定最近更新: 2021年11月24日

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•1.INFORMED CONSENT OBTAINED & SIGNED:
•Ability to understand and the willingness to sign a written informed consent document.
•2.DISEASE CHARACTERISTICS:
•Patients with newly diagnosed superficial transitinal cell carcinoma with compltetely resected papilary tumors and high probability of recurrence risk i.e. stage T1 Gr.2, T1 Gr3 & CIS AND Ta or T1 grade with an increased risk of recurrence defined as 2 tumors (primary and recurrent or 2 recurrences) with-in 1 year, 3 or more recurrences with in the last 6 months and/or carcinoma in situ on atleast one random biopsy.
•3. PATIENT CHARACTERISTICS:
•Age:18 completed years and above
•Performance status:ECOG 0-2
•Life expectancy:At least 24 weeks
•Hematopoietic:Absolute neutrophil count greter then or equal to 1,500/mm3
•Platelet count greter then or equal to 100,000/mm3
•Hemoglobin greter then or equal to 9.0 g/dL
•Re- Cystoscopy:No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR.

•Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
•No patient who has eczema should be allowed to participate in this study.
•Patients who are immuno-compromised should not be enrolled.
•Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition
•to agents used in the study.
•Pregnant women or nursing women are excluded from this study because agents used in the study
•have potential for teratogenic or abortifacient effects. Because there is known potential risk for
•adverse events in nursing infants secondary to treatment of the mother with investigational agent,
•breastfeeding should be discontinued if the mother is treated with investigational product.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,
•symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythemia, or psychiatric
•illness/social situations that would limit compliance with study requirements.
•Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
•Previous splenectomy
•Clinically significant active infection
•Patients with uncontrolled diabetes mellitus.

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