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

NCT ID: NCT00525408

Last Updated: 2012-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2013-01-31

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.

Conditions

Hormone Refractory Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Docetaxel+Mw

Group Type: EXPERIMENTAL

Mycobacterium w.

Intervention Type: BIOLOGICAL

Immunomodulator

1

Docetaxel

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Chemotherapeutic agent

Interventions

Mycobacterium w.

Immunomodulator

Intervention Type: BIOLOGICAL

Docetaxel

Chemotherapeutic agent

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cadila Pharnmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sudhir Rawal, MD

Role: PRINCIPAL_INVESTIGATOR

Rajiv Gandhi Cancer Institute

Arup Kumar Mandal, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Devakar Dalela, MD

Role: PRINCIPAL_INVESTIGATOR

Chatrapati Sahuji Mahraj Medical University

N K Mohanty, M.D.

Role: PRINCIPAL_INVESTIGATOR

Safdarjang Hospital

Jayesh Dhabalia, MD

Role: PRINCIPAL_INVESTIGATOR

SEth G S Medical College & KEM Hospital

Arun Chawla, MD

Role: PRINCIPAL_INVESTIGATOR

Kasturba Medical College

Sujata Patwardhan, MD

Role: PRINCIPAL_INVESTIGATOR

LTMMC & LTMGH

P G Jayaprakash, MD

Role: PRINCIPAL_INVESTIGATOR

RCC, Trivandrum

Amil Lal Bhat, MD

Role: PRINCIPAL_INVESTIGATOR

S.P. Medical College & A.G. Hospitals

Raju T Chacko, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Sushil Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

Choithram Hospital & Research Centre

Kim Mammen, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Ludhiana

K C Lakshmaiah, MD

Role: PRINCIPAL_INVESTIGATOR

Kidwai Memorial Istitute of Oncology

Rajeev Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Patel Hospital Pvt. Ltd.

Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

Kasturba Hospital,

Manipal, Karnataka, India

Regional Cancer Centre

Trivandrum, Kerala, India

Choithram Hospital & Research Centre

Indore, Madhya Pradesh, India

Seth G.S. Medical College & KEM Hospital

Pārel, Mumbai, India

Lokmanya Tilak Municipal Medical College & General Hospital

Sion, Mumbai, India

V.M. Medical College & Safdarjang Hospital

New Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute & Research Center

Rohini, National Capital Territory of Delhi, India

Patel Hospital Pvt. Ltd.

Jalandhar, Punjab, India

Christian Medical College, Ludhiana

Ludhiana, Punjab, India

S.P. Medical College & A. G. of Hospitals

Bikaner, Rajashthan, India

Christian Medical College

Vellore, Tamil Nadu, India

Chatrapati Sahuji Mahraj Medical University

Lucknow, Uttar Pradesh, India

Countries

India

Other Identifiers

CR-60/1260

Identifier Type: -

Identifier Source: org_study_id