HRPC: A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 2 Docetaxel+Mw |
Biological: Mycobacterium w.
Immunomodulator
|
| Active Comparator: 1 Docetaxel |
Drug: Docetaxel
Chemotherapeutic agent
|
Outcome Measures
Primary Outcome Measures
- Median Survival time [12 months]
- Time to Tumor Progression [12 Months]
Secondary Outcome Measures
- hematological toxicity, PSA levels, Quality of Life [12 months]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | V.M. Medical College & Safdarjang Hospital | New Delhi | Delhi | India | |
| 2 | Rajiv Gandhi Cancer Institute & Research Center | Rohini | Delhi | India | 110085 |
| 3 | Kidwai Memorial Institute of Oncology | Bangalore | Karnataka | India | 560029 |
| 4 | Kasturba Hospital, | Manipal | Karnataka | India | 576104 |
| 5 | Regional Cancer Centre | Trivandrum | Kerala | India | 695011 |
| 6 | Choithram Hospital & Research Centre | Indore | Madhya Pradesh | India | 452014 |
| 7 | Seth G.S. Medical College & KEM Hospital | Parel | Mumbai | India | 400012 |
| 8 | Lokmanya Tilak Municipal Medical College & General Hospital | Sion | Mumbai | India | 400022 |
| 9 | Patel Hospital Pvt. Ltd. | Jalandhar | Punjab | India | 144001 |
| 10 | Christian Medical College, Ludhiana | Ludhiana | Punjab | India | 141008 |
| 11 | S.P. Medical College & A. G. of Hospitals | Bikaner | Rajashthan | India | 334003 |
| 12 | Christian Medical College | Vellore | Tamil Nadu | India | 632002 |
| 13 | Chatrapati Sahuji Mahraj Medical University | Lucknow | Uttar Pradesh | India | |
| 14 | Post Graduate Institute of Medical Education and Research | Chandigarh | India | 160012 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-60/1260