Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder (STCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00694915
First received: May 29, 2008
Last updated: May 3, 2012
Last verified: May 2012

May 29, 2008
May 3, 2012
August 2008
February 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00694915 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
  • Biological: Mycobacterium w
    Immunomodulator
  • Biological: BCG (Bacillus Calmette-Guerin)
    Immunotherapeutic agent
    Other Name: Bacillus Calmette Guerin
  • Experimental: Mw
    Mycobacterium w
    Intervention: Biological: Mycobacterium w
  • Active Comparator: BCG
    bacillus Calmette-Guerin (BCG)
    Intervention: Biological: BCG (Bacillus Calmette-Guerin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
122
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00694915
CR-60/9150
Yes
Cadila Pharnmaceuticals
Cadila Pharnmaceuticals
Not Provided
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
Cadila Pharnmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP