Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 14
- 主要终点
- Time to Tumor Progression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Docetaxel
干预措施: Docetaxel (Drug)
2
Docetaxel+Mw
干预措施: Mycobacterium w. (Biological)
结局指标
主要结局
Time to Tumor Progression
时间窗: 12 Months
Median Survival time
时间窗: 12 months
次要结局
- hematological toxicity, PSA levels, Quality of Life(12 months)