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

Cadila Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Hormone Refractory Prostate Cancer

Treatments

Biological: Mycobacterium w.

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00525408

CR-60/1260

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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