NCT00081172已完成2 期
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
详细描述
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591.
- Determine the measurable disease response rate in patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug.
- Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug.
- Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients.
- Determine the survival rate in patients treated with this drug.
- Determine the targeting of this drug to known tumor sites in these patients.
- Determine the tumor-absorbed radiation dose in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Metastatic disease
- •Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:
- •New osseous lesions on bone scan
- •Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan
- •Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy
- •Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement
- •PSA must be ≥ 5 ng/mL and ≥ 25% above the previous nadir
- •Measurable or evaluable disease
- •Serum testosterone ≤ 50 ng/dL
- •No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan")
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Hematocrit ≥ 30%
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 150,000/mm^3
- •No serious hematologic illness that would preclude study participation
- •AST ≤ 2 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •PTT normal
- •PT normal OR
- •INR normal
- •No serious hepatic illness that would preclude study participation
- •Creatinine ≤ 2.5 mg/dL
- •Calcium ≤ 11 mg/dL
- •No serious renal illness that would preclude study participation
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •No active angina pectoris
- •No prior deep vein thrombophlebitis within the past 3 months
- •No other serious cardiac illness that would preclude study participation
- •No pulmonary embolus within the past 3 months
- •No other serious respiratory illness that would preclude study participation
- •Fertile patients must use effective contraception
- •HIV negative
- •No serious CNS illness that would preclude study participation
- •No active serious infection not controlled by antibiotics
- •No other serious illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior red blood cell or platelet transfusions
- •More than 2 weeks since prior hematopoietic growth factors
- •No prior monoclonal antibody therapy except ProstaScint®
- •No other concurrent monoclonal antibody-based therapy
- 另有 31 项未显示
排除标准
- 未提供
结局指标
主要结局
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
次要结局
未报告次要终点
研究者
研究点 (3)
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