Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder (STCC)
This study is currently recruiting participants.
Verified by Cadila Pharnmaceuticals, October 2008
Sponsored by: Cadila Pharnmaceuticals
Information provided by: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT00694915
  Purpose

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
Superficial Transitional Cell Carcinoma of Bladder
Biological: Mycobacterium w
Biological: BCG (bacillus Calmette-Guerin)
Phase II

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: BCG Vaccine
U.S. FDA Resources
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

Further study details as provided by Cadila Pharnmaceuticals:

Primary Outcome Measures:
  • Recording of any clinical adverse reactions at anytime during the study for assessment of safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period [ Time Frame: 15 ] [ Designated as safety issue: No ]

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
Mw: Experimental
Mycobacterium w
Biological: Mycobacterium w
Immunomodulator
BCG: Active Comparator
bacillus Calmette-Guerin (BCG)
Biological: BCG (bacillus Calmette-Guerin)
Immunotherapeutic agent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694915

Contacts
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

Locations
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            
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: 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
  More Information

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

Keywords provided by Cadila Pharnmaceuticals:
STCC (Superficial Transitional Cell Carcinoma)

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009