NCT00096525已完成2 期
Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Efficacy (complete and partial response)
研究概览
简要总结
RATIONALE: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
- Determine the time to disease progression in patients treated with this drug.
Secondary
- Determine the safety of this drug in these patients.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed renal cell carcinoma (RCC)
- •Advanced or unresectable disease
- •At least 1 measurable lesion
- •No active brain metastases
- •Prior brain metastases allowed provided patient has been treated with radiotherapy or surgery AND remains asymptomatic for ≥ 6 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •No hepatitis A, B, or C infection
- •Creatinine ≤ 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No known hypersensitivity to thalidomide
- •No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No more than 1 prior systemic immunotherapy regimen for RCC
- •No prior lenalidomide (CC-5013)
- •No prior or concurrent thalidomide
- •Chemotherapy
- •No more than 1 prior systemic chemotherapy regimen for RCC
- •Endocrine therapy
- •No more than 1 prior systemic hormonal therapy regimen for RCC
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior surgery and recovered
- •No more than 1 other prior systemic therapy regimen for RCC
- •No other concurrent anticancer therapies
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Efficacy (complete and partial response)
次要结局
- Toxicity
- Adverse events
研究者
研究点 (1)
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