Status:
COMPLETED
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder
Lead Sponsor:
Cadila Pharnmaceuticals
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determinin...
Eligibility Criteria
Inclusion
- 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 be enrolled.
- 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.
Exclusion
- 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 arrhythmia, 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.
Key Trial Info
Start Date :
August 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00694915
Start Date
August 28 2008
End Date
October 7 2015
Last Update
August 17 2021
Active Locations (15)
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1
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, India
2
Urocare Hospital
Rajkot, Gujarat, India, 360002
3
Indira Gandhi Medical College
Shimla, Himachal Pradesh, India, 171001
4
N.R.R. Hospital
Bangalore, Karnataka, India, 560090