Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder (STCC)
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| ClinicalTrials.gov Identifier: NCT00694915 |
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Recruitment Status : Unknown
Verified May 2012 by Cadila Pharnmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : June 11, 2008
Last Update Posted : May 4, 2012
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Sponsor:
Cadila Pharnmaceuticals
Information provided by (Responsible Party):
Cadila Pharnmaceuticals
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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 determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer | Biological: Mycobacterium w Biological: BCG (Bacillus Calmette-Guerin) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 122 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | August 2008 |
| Estimated Primary Completion Date : | February 2014 |
| Estimated Study Completion Date : | February 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Bladder cancer
Drug Information available for:
BCG Vaccine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mw
Mycobacterium w
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Biological: Mycobacterium w
Immunomodulator |
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Active Comparator: BCG
bacillus Calmette-Guerin (BCG)
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Biological: BCG (Bacillus Calmette-Guerin)
Immunotherapeutic agent
Other Name: Bacillus Calmette Guerin |
Primary Outcome Measures :
- Recording of any clinical adverse reactions at anytime during the study for assessment of safety [ Time Frame: 24 months ]
- Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology [ Time Frame: 24 months ]
Secondary Outcome Measures :
- Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities [ Time Frame: 24 months ]
- Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period [ Time Frame: 15 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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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 Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694915
Locations
| India | |
| Urocare Hospital | |
| Rajkot, Gujarat, India, 360002 | |
| Muljibhai Patel Urological Hospital | |
| Nadiad, Gujrat, India | |
| Indira Gandhi Medical College | |
| Shimla, Himachal Pradesh, India, 171001 | |
| N.R.R. Hospital | |
| Bangalore, Karnataka, India, 560090 | |
| Kasturba Medical college and Hospital | |
| Manipal, Karnataka, India, 576104 | |
| Lourdes Hospital | |
| Kochi, Kerala, India, 682012 | |
| Choithram Hospital and Research Centre | |
| Indore, Madhya Pradesh, India, 452014 | |
| Cancer Hospital and Research Institute | |
| Gwalior, Madya Pradesh, India, 474009 | |
| Seth G S Medical College & K E M Hospital | |
| Parel, Mumbai, India, 400012 | |
| Christian Medical College | |
| Ludhiana, Punjab, India, 141008 | |
| P.B.M. Hospital & A.G. of Hospitals | |
| Bikaner, Rajasthan, India, 334003 | |
| IPGMER, S.S.K.M. Hospital | |
| Kolkata, West Bengal, India, 700020 | |
| Post Graduate Institute of Medical Education and Research | |
| Chandigarh, India, 160012 | |
| Dr. Ram Manohar Lohia Hospital & PGIMER | |
| New Delhi, India, 110001 | |
| V M Medical College & Safdarjang Hospital | |
| New Delhi, India, 110029 | |
Sponsors and Collaborators
Cadila Pharnmaceuticals
Investigators
| Principal Investigator: | Mahesh Desai, MD | Muljibhai Patel Urological Hospital | |
| Principal Investigator: | N K Mohanty, MD | V M Medical College & Safdarjang Hospital | |
| Principal Investigator: | Amillal Bhat, MD | S P Medical College & AG of Hospitals | |
| Principal Investigator: | Sujata Patwardhan, MD | Seth G S Medical College & K E M Hospital | |
| Principal Investigator: | Kim Mammen, MD | Christian Medical College, Vellore, India | |
| Principal Investigator: | Sushil Bhatia, MD | Choithram Hospital and Research Centre | |
| Principal Investigator: | B. R. Srivastav, MD | Cancer Hospital and Research Institute | |
| Principal Investigator: | Jitendra Amlani, MD | Urocare Hospital | |
| Principal Investigator: | Anup Kundu, MD | Institute of Post Graduate Medical Education & Research, S. S. K. M. Hospital | |
| Principal Investigator: | H. K. Moorthy, MD | Lourdes Hospital | |
| Principal Investigator: | Shrawan K. Singh, MD | Post Graduate Institute of Medical Education & Research | |
| Principal Investigator: | Purshottam K. Puri, MD | Indira Gandhi Medical College | |
| Principal Investigator: | Rajeev Sood, MD | Dr. Ram Manohar Lohia Hospital & PGIMER | |
| Principal Investigator: | Padmaraj Hegde, MD | Kasturba Medical College & Hospital | |
| Principal Investigator: | Yathish Kumar, MD | N.R.R. Hospital |
| Responsible Party: | Cadila Pharnmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00694915 History of Changes |
| Other Study ID Numbers: |
CR-60/9150 |
| First Posted: | June 11, 2008 Key Record Dates |
| Last Update Posted: | May 4, 2012 |
| Last Verified: | May 2012 |
Keywords provided by Cadila Pharnmaceuticals:
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STCC (Superficial Transitional Cell Carcinoma) |
Additional relevant MeSH terms:
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Carcinoma Urinary Bladder Neoplasms Mycobacterium Infections Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Urinary Bladder Diseases Urologic Diseases Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections BCG Vaccine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |