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Sponsored by: |
Cadila Pharnmaceuticals |
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Information provided by: | Cadila Pharnmaceuticals |
ClinicalTrials.gov Identifier: | NCT00694915 |
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 | Intervention | Phase |
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Superficial Transitional Cell Carcinoma of Bladder |
Biological: Mycobacterium w Biological: BCG (bacillus Calmette-Guerin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mw: Experimental
Mycobacterium w
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Biological: Mycobacterium w
Immunomodulator
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BCG: Active Comparator
bacillus Calmette-Guerin (BCG)
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Biological: BCG (bacillus Calmette-Guerin)
Immunotherapeutic agent
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Hemoglobin ≥9.0g/dL
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:
Contact: Vikas M Vaishnavi, MD | 91- 2718 - 225001 ext 469-74 | drv.vaishnavi@cadilapharma.co.in |
Contact: Bhaswat S Chakraborty, PhD | 91-2714-221481 ext 170 | drb.chakraborty@cadilapharma.co.in |
India | |
V M Medical College & Safdarjang Hospital | Recruiting |
New Delhi, India, 110029 | |
Contact: N K Mohanty, MD nayankm@yahoo.co.in | |
Principal Investigator: N K Mohanty, MD | |
India, Gujrat | |
Muljibhai Patel Urological Hospital | Recruiting |
Nadiad, Gujrat, India | |
Contact: Mahesh Desai, MD mrdesai@mpuh.org | |
Principal Investigator: Mahesh Desai, MD | |
India, Madhya Pradesh | |
Choithram Hospital and Research Centre | Recruiting |
Indore, Madhya Pradesh, India, 452014 | |
Contact: Sushil Bhatia, MD drsushilbhatia@rediffmail.com | |
Principal Investigator: Sushil Bhatia, MD | |
India, Mumbai | |
Seth G S Medical College & K E M Hospital | Not yet recruiting |
Parel, Mumbai, India, 400012 | |
Contact: Jayesh Dhabalia, MD drjayeshdhabalia@rediffmail.com | |
Principal Investigator: Jayesh Dhabalia, MD | |
India, Punjab | |
Christian Medical College | Recruiting |
Ludhiana, Punjab, India, 141008 | |
Contact: Kim Mammen, MD kjmammen@gmail.com | |
Principal Investigator: Kim Mammen, MD | |
India, Rajasthan | |
Acharya Tulsi Regional Cancer Treatment & Research Institute | Recruiting |
Bikaner, Rajasthan, India, 334003 | |
Contact: Amil Lal Bhat, MD amilalbhat@rediffmail.com | |
Principal Investigator: Amil Lal Bhat, MD |
Principal Investigator: | Mahesh Desai, MD | Muljibhai Patel Urological Hospital |
Principal Investigator: | N K Mohanty, MD | V M Medical College & Safdarjang Hospital |
Principal Investigator: | Amil Lal Bhat, MD | S P Medical College & AG of Hospitals |
Principal Investigator: | Jayesh Dhabalia, 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 |
Responsible Party: | Cadila Pharmaceuticals Ltd. ( Dr. Bhaswat Chakraborty, Vice President-Clinical Research Organization ) |
Study ID Numbers: | CR-60/9150 |
Study First Received: | May 29, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00694915 |
Health Authority: | India: Drugs Controller General of India; United States: Food and Drug Administration |
STCC (Superficial Transitional Cell Carcinoma) |
BCG Vaccine Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Recurrence Carcinoma Urologic Diseases Mycobacterium Infections Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |