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

March 9, 2012 updated by: Cadila Pharnmaceuticals

Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research
    • Delhi
      • New Delhi, Delhi, India
        • V.M. Medical College & Safdarjang Hospital
      • Rohini, Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research Center
    • Karnataka
      • Bangalore, Karnataka, India, 560029
        • Kidwai Memorial Institute of Oncology
      • Manipal, Karnataka, India, 576104
        • Kasturba Hospital,
    • Kerala
      • Trivandrum, Kerala, India, 695011
        • Regional Cancer Centre
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452014
        • Choithram Hospital & Research Centre
    • Mumbai
      • Parel, Mumbai, India, 400012
        • Seth G.S. Medical College & KEM Hospital
      • Sion, Mumbai, India, 400022
        • Lokmanya Tilak Municipal Medical College & General Hospital
    • Punjab
      • Jalandhar, Punjab, India, 144001
        • Patel Hospital Pvt. Ltd.
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College, Ludhiana
    • Rajashthan
      • Bikaner, Rajashthan, India, 334003
        • S.P. Medical College & A. G. of Hospitals
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632002
        • Christian Medical College
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • Chatrapati Sahuji Mahraj Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2
Docetaxel+Mw
Biological: Mycobacterium w.
Immunomodulator
Active Comparator: 1
Docetaxel
Drug: Docetaxel
Chemotherapeutic agent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Median Survival time
Time Frame: 12 months
12 months
Time to Tumor Progression
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
hematological toxicity, PSA levels, Quality of Life
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cadila Pharnmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-60/1260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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