Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
18 Years
N/A
Male
Hormone Refractory Prostate Cancer
Trial Information
Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median Survival time
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Sudhir Rawal, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rajiv Gandhi Cancer Institute
Authority:
India: Drugs Controller General of India
Study ID:
CR-60/1260
NCT ID:
NCT00525408
Start Date:
November 2007
Completion Date:
January 2013
Related Keywords:
- Hormone Refractory Prostate Cancer
- HRPC
- Metastatic Hormone Refractory Prostate Cancer
- Docetaxel
- Mycobacterium w
- Mycobacterium Infections
- Prostatic Neoplasms
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