Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.
详细描述
This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age ≥ 18 years
- •Histologically-confirmed adenocarcinoma of the prostate
- •Hormone-refractory prostate cancer
- •Failed 1st-line docetaxel-containing regimen
- •No prior immunotherapy including:
- •Minimum prostate-specific antigen (PSA) > 5 mg/dL and rising according to the PSA Consensus Criteria
- •Karnofsky Performance Status (KPS) > 60%
- •Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
- •Life expectancy > 6 months
排除标准
- •Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist
- •Use of herbal products known to decrease PSA levels
- •Use of supplements or complementary medicines, except for:
- •Conventional multivitamin supplements
- •Soy supplements
- •Vitamin E
- •Initiation of bisphosphonates within one month prior to enrollment or throughout the study
- •Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
- •Major surgery or radiation therapy completed < 4 weeks prior to enrollment
- •Any concomitant second malignancy other than non-melanoma skin cancer
- •Any concomitant serious infection
- •Any nonmalignant medical illness
- •Absolute neutrophil count (ANC) < 1,500/µL
- •Platelet count < 100,000 µL
- •Hemoglobin < 8 mg/dL
- •Total bilirubin greater than 1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases
- •Ejection fraction < 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
- •Noncompliance with study procedures
研究组 & 干预措施
GM-CSF Plus Mitoxantrone
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.
干预措施: Mitoxantrone (Drug)
GM-CSF Plus Mitoxantrone
GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.
干预措施: GM-CSF (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 18 months
Assessed as the time from the 1st dose of study drug to death or disease progression (increase \>25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of \>20% KPS)
次要结局
- Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)(18 months)
- Overall Survival (OS)(18 months)
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University