Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

NCT00694915 | Completed Phase 2 DMC

• 1 other identifier: CR-60/9150
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 15

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.

Conditions

Bladder Cancer

Keywords

STCC (Superficial Transitional Cell Carcinoma)

Outcome Measures

Primary Outcomes (2)

• Recording of any clinical adverse reactions at anytime during the study for assessment of safety

  24 months

• Recurrence Rate-Evaluated after 3 months by doing sonography, cystoscopy, and cytology

  24 months

Secondary Outcomes (2)

• Quality of Life- The measure of an individual's sense of well-being and ability to carry out various activities

  24 months

• Time to Tumor progression -will be evaluated every 3 months for 15 months during the study period

  15

Study Arms (2)

Mw

EXPERIMENTAL

Mycobacterium w

Biological: Mycobacterium w

BCG

ACTIVE COMPARATOR

bacillus Calmette-Guerin (BCG)

Biological: BCG (Bacillus Calmette-Guerin)

Interventions

Mycobacterium w BIOLOGICAL

Immunomodulator

Mw

BCG (Bacillus Calmette-Guerin) BIOLOGICAL

Immunotherapeutic agent

Also known as: Bacillus Calmette Guerin

BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (15)

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Location

Urocare Hospital

Rajkot, Gujarat, 360002, India

Location

Indira Gandhi Medical College

Shimla, Himachal Pradesh, 171001, India

Location

N.R.R. Hospital

Bangalore, Karnataka, 560090, India

Location

Kasturba Medical college and Hospital

Manipal, Karnataka, 576104, India

Location

Lourdes Hospital

Kochi, Kerala, 682012, India

Location

Choithram Hospital and Research Centre

Indore, Madhya Pradesh, 452014, India

Location

Cancer Hospital and Research Institute

Gwalior, Madya Pradesh, 474009, India

Location

Seth G S Medical College & K E M Hospital

Pārel, Mumbai, 400012, India

Location

Christian Medical College

Ludhiana, Punjab, 141008, India

Location

P.B.M. Hospital & A.G. of Hospitals

Bikaner, Rajasthan, 334003, India

Location

IPGMER, S.S.K.M. Hospital

Kolkata, West Bengal, 700020, India

Location

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Dr. Ram Manohar Lohia Hospital & PGIMER

New Delhi, 110001, India

Location

V M Medical College & Safdarjang Hospital

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mycobacterium w vaccine; BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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, Shimla

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 11, 2008
• Study Start: August 28, 2008
• Primary Completion: March 31, 2014
• Study Completion: October 7, 2015
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

IN (15)