A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Define the PSA Response Rate.
研究概览
简要总结
The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.
详细描述
To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer.
Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of prostate adenocarcinoma.
- •Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
- •Progressed following discontinuation of anti-androgen therapy, if received.
- •Serum testosterone < 50 ng/ml
排除标准
- •Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
- •Use of PC-SPES within 4 weeks of treatment.
- •Use of red blood cell or platelet transfusions within 4 weeks of treatment.
- •Use of hematopoietic growth factors within 4 weeks of treatment.
- •Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
- •Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
- •Prior radiation therapy encompassing >25% of skeleton.
- •Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
- •Active angina pectoris or NY Heart Association Class III-IV.
- •History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
- •Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
- •Prior monoclonal antibody therapy with the exception of ProstaScint®
- •Prior investigational therapy (medications or devices) within 6 weeks of treatment.
- •Known history of HIV
研究组 & 干预措施
All patients
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
干预措施: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591) (Drug)
结局指标
主要结局
Define the PSA Response Rate.
时间窗: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
PSA response rate corresponds to change form baseline in PSA at any of the time points specified.
Define the Measurable Disease Response Rate.
时间窗: Disease will be assessed at baseline and day 85.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
次要结局
- Assess the Survival Rate of Patients Following Treatment.(From baseline through study completion)
- Define the Toxicity of 177Lu-J591 Given as Single Dose.(From baseline until end of treatment phase (12 weeks))
- Define the Incidence of Human Anti-J591 Antibody (HAHA) Response.(HAHA samples will be drawn at baseline and Day 85.)
- Define the Duration of Biochemical PSA and/or Measurable Disease Response.(At baseline, and up to death)
- Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).(Bone scan will be performed at baseline and Day 85.)
- Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.(Scans will be performed between day 6 and 8.)