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

Phase 2

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
2	Mycobacterium w.	Docetaxel+Mw
1	Docetaxel	Docetaxel

Primary Outcome Measures

Name	Time	Method
Median Survival time	12 months
Time to Tumor Progression	12 Months

Secondary Outcome Measures

Name	Time	Method
hematological toxicity, PSA levels, Quality of Life	12 months

Locations (14): Regional Cancer Centre
🇮🇳
Trivandrum, Kerala, India
Post Graduate Institute of Medical Education and Research
🇮🇳
Chandigarh, India
V.M. Medical College & Safdarjang Hospital
🇮🇳
New Delhi, Delhi, India
Christian Medical College
🇮🇳
Vellore, Tamil Nadu, India
Rajiv Gandhi Cancer Institute & Research Center
🇮🇳
Rohini, Delhi, India
Choithram Hospital & Research Centre
🇮🇳
Indore, Madhya Pradesh, India
Kidwai Memorial Institute of Oncology
🇮🇳
Bangalore, Karnataka, India
Seth G.S. Medical College & KEM Hospital
🇮🇳
Parel, Mumbai, India
Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳
Sion, Mumbai, India
Kasturba Hospital,
🇮🇳
Manipal, Karnataka, India
Patel Hospital Pvt. Ltd.
🇮🇳
Jalandhar, Punjab, India
S.P. Medical College & A. G. of Hospitals
🇮🇳
Bikaner, Rajashthan, India
Chatrapati Sahuji Mahraj Medical University
🇮🇳
Lucknow, Uttar Pradesh, India
Christian Medical College, Ludhiana
🇮🇳
Ludhiana, Punjab, India