Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence
- Ability to understand and willingness to sign a written informed consent.
- Patients with newly diagnosed superficial transitional cell carcinoma with completely
resected papillary tumors and high probability of recurrence risk i.e. stage T1 Grade
2, T1 Grade 3 & CIS.
and Ta or T1 disease with an increased risk of recurrence defined as 2 tumors (primary and
recurrent or 2 recurrences) within 1 year, 3 or more within the last 6 months and/ or
carcinoma in situ on at least one random biopsy.
- 18 years or above
- ECOG of 0-2 range
- life expectancy is at least 24 weeks.
- Absolute neutrophil count≥1,500/c.mm
- platelet count≥100,000//c.mm
- Hemoglobin ≥9.0g/dL
- No patient who has eczema will be allowed to participate in this study.
- Patients who are immuno-compromised will not be enrolled.
- Patients with severe hepatic dysfunctions or with evidence of Cirrhosis will not
- Patients with uncontrolled diabetes mellitus will not be enrolled in the study
- No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR
Note: The effects of Investigational product on the developing human fetus is at the
recommended therapeutic dose are unknown. For this reason and because other therapeutic
agents used in this trial are known to be teratogenic, women of child bearing potential
and men must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study participation.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately.
- Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the
- 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
- 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
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study
- Previous splenectomy
- Clinically significant active infection
- Patients with uncontrolled diabetes mellitus.