Spots Global Cancer Trial Database for A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
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Trial Identification
Brief Title: A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
Official Title: Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
Study ID: NCT00525408
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
V.M. Medical College & Safdarjang Hospital, New Delhi, Delhi, India
Rajiv Gandhi Cancer Institute & Research Center, Rohini, Delhi, 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, Parel, Mumbai, India
Lokmanya Tilak Municipal Medical College & General Hospital, Sion, Mumbai, 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
Post Graduate Institute of Medical Education and Research, Chandigarh, , India
Contact Details
Name: Sudhir Rawal, MD
Affiliation: Rajiv Gandhi Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Arup Kumar Mandal, MD
Affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
Role: PRINCIPAL_INVESTIGATOR
Name: Devakar Dalela, MD
Affiliation: Chatrapati Sahuji Mahraj Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: N K Mohanty, M.D.
Affiliation: Safdarjang Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jayesh Dhabalia, MD
Affiliation: SEth G S Medical College & KEM Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Arun Chawla, MD
Affiliation: Kasturba Medical College
Role: PRINCIPAL_INVESTIGATOR
Name: Sujata Patwardhan, MD
Affiliation: LTMMC & LTMGH
Role: PRINCIPAL_INVESTIGATOR
Name: P G Jayaprakash, MD
Affiliation: RCC, Trivandrum
Role: PRINCIPAL_INVESTIGATOR
Name: Amil Lal Bhat, MD
Affiliation: S.P. Medical College & A.G. Hospitals
Role: PRINCIPAL_INVESTIGATOR
Name: Raju T Chacko, MD
Affiliation: Christian Medical College, Vellore, India
Role: PRINCIPAL_INVESTIGATOR
Name: Sushil Bhatia, MD
Affiliation: Choithram Hospital & Research Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Kim Mammen, MD
Affiliation: Christian Medical College, Ludhiana
Role: PRINCIPAL_INVESTIGATOR
Name: K C Lakshmaiah, MD
Affiliation: Kidwai Memorial Istitute of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Rajeev Gupta, MD
Affiliation: Patel Hospital Pvt. Ltd.
Role: PRINCIPAL_INVESTIGATOR
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