A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 864
- 试验地点
- 56
- 主要终点
- Disease-free Survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 (WX-G250) vs placebo in an adjuvant setting.
Secondary
- Evaluate the safety of these drugs in these patients.
- Assess the quality of life of patients treated with this drug.
- Perform pharmacokinetic analysis of WX-G250.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary clear cell renal cell carcinoma
- •Meets 1 of the following high risk criteria:
- •T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0
- •Any T stage and N + disease and M0
- •T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other nuclear grading system with at least 3 grades)
- •Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks
- •No evidence of macroscopic or microscopic residual disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count > 100,000/mm^3
- •WBC > 3,000/mm^3
- •Hemoglobin > 10 g/dL
- •AST and ALT < 3 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •Hepatitis B surface antigen (HbsAg) negative
- •Hepatitis C antibody negative
- •Creatinine < 2.0 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV I and II negative
- •No concurrent unrelated illness which can significantly jeopardize patients' clinical status
- •No active infection
- •No inflammation
- •No medical condition or laboratory abnormalities that would preclude study participation
- •No other malignancies within the past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 5 years since prior immunotherapy
- •No prior murine or chimeric antibody therapy
- •Chemotherapy
- •More than 5 years since prior chemotherapy
- •Endocrine therapy
- •No concurrent corticosteroids above Cushing dose for another disease
- •Physiologic corticosteroid replacement therapy allowed at discretion of the primary investigator
- •Radiotherapy
- •More than 5 years since prior radiotherapy
- •See Disease Characteristics
- •No prior organ transplantation
- •No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus)
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
干预措施: placebo (Other)
Arm I
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
干预措施: girentuximab (Biological)
结局指标
主要结局
Disease-free Survival
时间窗: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
Overall Survival
时间窗: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)
Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.
次要结局
- Pharmacokinetics of WX-G250(Week 8)
- Quality of Life - Global Health Status(At 12 months)