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

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: Terminated
• Conditions: Hormone Refractory Prostate Cancer
• Intervention / Treatment: Biological: Mycobacterium w.; Drug: Docetaxel

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: Interventional
• Enrollment (Actual): 134
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; Docetaxel+Mw	Biological: Mycobacterium w.; Immunomodulator
Active Comparator: 1; Docetaxel	Drug: Docetaxel; Chemotherapeutic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median Survival time	12 months
Time to Tumor Progression	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
hematological toxicity, PSA levels, Quality of Life	12 months

Collaborators and Investigators

• Sponsor: Cadila Pharnmaceuticals
• Investigators: 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

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: September 1, 2007
• First Submitted That Met QC Criteria: September 4, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Estimate): March 12, 2012
• Last Update Submitted That Met QC Criteria: March 9, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Docetaxel; HRPC; Metastatic Hormone Refractory Prostate Cancer; Mycobacterium w
• Additional Relevant MeSH Terms: Infections; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Prostatic Neoplasms; Mycobacterium Infections; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CR-60/1260