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

Study Description

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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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Mw; Mycobacterium w	Biological: Mycobacterium w; Immunomodulator
Active Comparator: BCG; bacillus Calmette-Guerin (BCG)	Biological: BCG (Bacillus Calmette-Guerin); Immunotherapeutic agent; Other Name: Bacillus Calmette Guerin

Outcome Measures

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Primary Outcome Measures :

1. Recording of any clinical adverse reactions at anytime during the study for assessment of safety [ Time Frame: 24 months ]
2. Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities [ Time Frame: 24 months ]
2. Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period [ Time Frame: 15 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

• 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

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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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:	NCT00694915 History of Changes
Other Study ID Numbers:	CR-60/9150
First Posted:	June 11, 2008
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by Cadila Pharnmaceuticals:

STCC (Superficial Transitional Cell Carcinoma)

Additional relevant MeSH terms:

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