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Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder (STCC)
This study is currently recruiting participants.
Verified by Cadila Pharnmaceuticals, February 2009
Sponsored by: Cadila Pharnmaceuticals
Information provided by: Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier: NCT00694798
  Purpose

The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.


Condition Intervention Phase
Superficial Transitional Cell Carcinoma
Biological: Mycobacterium w
Phase I

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma

Further study details as provided by Cadila Pharnmaceuticals:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 15 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mw: Experimental
Mycobacterium w
Biological: Mycobacterium w
Immunomodulator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed Consent obtained & signed:

    Ability to understand and the willingness to sign a written informed consent document.

  2. Disease characteristics:

    Patients with BCG refractory superficial transitional cell carcinoma, refractory carcinoma in situ, multiple unresected T1 and Ta high grade.

    BCG-refractory STCC is defined as when there is failure to achieve disease-free state at six months after initiation of BCG therapy either as primary or repeat therapy or recurrence of tumor within three months of completion of adequate induction or maintenance therapy or adequate retreatment. .

  3. Patient Characteristics:

Age: 18 completed years and above Performance status: ECOG 0-2 Life expectancy: At least 24 weeks Hematopoietic:Hemoglobin ≥ 9.0 g/dL

Co-morbidity

  • 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.

Note: The effects of Investigational product on the developing human fetus 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.
  • Intractable urinary tract infection.
  • 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 arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Previous splenectomy
  • Clinically significant active infection
  • Patients with uncontrolled diabetes mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694798

Contacts
Contact: Bhaswat S Chakraborty, PhD. 91-2714-221481 ext 170 drb.chakraborty@cadilapharma.co.in

Locations
India, Gujrat
Muljibhai Patel Urological Hospital Not yet 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, Rajasthan
Acharya Tulsi Regional Cancer Treatment & Research Institute Recruiting
Bikaner, Rajasthan, India
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: Amil Lal Bhat, MD S P Medical College & AG of Hospital
Principal Investigator: Sushil Bhatia, MD Choithram Hospital and Research Centre
  More Information

No publications provided

Responsible Party: Cadila Pharmaceuticals Ltd. ( Dr. Bhaswat Chakraborty, Vice President-Clinical Research Organization )
Study ID Numbers: CR-80/8230
Study First Received: June 3, 2008
Last Updated: February 10, 2009
ClinicalTrials.gov Identifier: NCT00694798  
Health Authority: India: Drugs Controller General of India;   United States: Food and Drug Administration

Keywords provided by Cadila Pharnmaceuticals:
STCC
Superficial Transitional Cell Carcinoma- BCG refractor

Study placed in the following topic categories:
Urinary Bladder Neoplasms
Mycobacterium Infections
Carcinoma, Transitional Cell
Transitional cell carcinoma
Bladder neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2009