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A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer (HRPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525408
Recruitment Status : Terminated (Interim Analysis report indicates trial futility)
First Posted : September 5, 2007
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):
Cadila Pharnmaceuticals

Tracking Information
First Submitted Date  ICMJE September 1, 2007
First Posted Date  ICMJE September 5, 2007
Last Update Posted Date March 12, 2012
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
  • Median Survival time [ Time Frame: 12 months ]
  • Time to Tumor Progression [ Time Frame: 12 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
Overall survival rate & quality of life of patients [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
hematological toxicity, PSA levels, Quality of Life [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
PSA level, Tumor response [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
Official Title  ICMJE Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
Brief Summary This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.
Detailed Description Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hormone Refractory Prostate Cancer
Intervention  ICMJE
  • Biological: Mycobacterium w.
    Immunomodulator
  • Drug: Docetaxel
    Chemotherapeutic agent
Study Arms  ICMJE
  • Experimental: 2
    Docetaxel+Mw
    Intervention: Biological: Mycobacterium w.
  • Active Comparator: 1
    Docetaxel
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2012)
134
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2007)
176
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
  • Disease progression during antiandrogen therapy, having surgical or medical castration status.
  • Karnofsky Performance Status 50-100
  • Normal cardiac function
  • Life expectancy at least 24 weeks.
  • Laboratory criteria for eligibility will include
  • A neutrophil count of at least 1500 per cubic millimeter
  • A hemoglobin level of at least 9 gm%
  • A platelet count of at least 1000,000 per cubic millimeter.
  • A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution.
  • Serum creatinine levels not more than 1.5 times the upper limit of the normal range
  • Written informed consent

Exclusion Criteria:

  • Prior treatment with cytotoxic agents or radioisotopes
  • Estrogen use for at least three months
  • History of another cancer within the preceding five years (except basal or squamous-cell skin cancer)
  • Brain or leptomeningeal metastases
  • Symptomatic peripheral neuropathy of grade 2 or higher
  • Uncontrolled intercurrent illness that would limit compliance with study requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525408
Other Study ID Numbers  ICMJE CR-60/1260
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cadila Pharnmaceuticals
Study Sponsor  ICMJE Cadila Pharnmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sudhir Rawal, MD Rajiv Gandhi Cancer Institute
Principal Investigator: Arup Kumar Mandal, MD Post Graduate Institute of Medical Education and Research
Principal Investigator: Devakar Dalela, MD Chatrapati Sahuji Mahraj Medical University
Principal Investigator: N K Mohanty, M.D. Safdarjang Hospital
Principal Investigator: Jayesh Dhabalia, MD SEth G S Medical College & KEM Hospital
Principal Investigator: Arun Chawla, MD Kasturba Medical College
Principal Investigator: Sujata Patwardhan, MD LTMMC & LTMGH
Principal Investigator: P G Jayaprakash, MD RCC, Trivandrum
Principal Investigator: Amil Lal Bhat, MD S.P. Medical College & A.G. Hospitals
Principal Investigator: Raju T Chacko, MD Christian Medical College, Vellore, India
Principal Investigator: Sushil Bhatia, MD Choithram Hospital & Research Centre
Principal Investigator: Kim Mammen, MD Christian Medical College, Ludhiana
Principal Investigator: K C Lakshmaiah, MD Kidwai Memorial Istitute of Oncology
Principal Investigator: Rajeev Gupta, MD Patel Hospital Pvt. Ltd.
PRS Account Cadila Pharnmaceuticals
Verification Date March 2012

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