临床试验/NCT00403169

NCT00403169已完成2 期

Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)

The Cleveland Clinic1 个研究点分布在 1 个国家目标入组 28 人开始时间: 2004年8月1日最近更新: 2026年7月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: The Cleveland Clinic
入组人数: 28
试验地点: 1
主要终点: Overall response

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking 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:

Evaluate the best response in patients with advanced or unresectable renal cell carcinoma (RCC) treated with lenalidomide.
Evaluate the response duration, time to tumor progression, and survival of patients with advanced RCC treated with lenalidomide.
Evaluate the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months.

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 120 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•DISEASE CHARACTERISTICS:
•Histologically or cytologically confirmed renal cell carcinoma (RCC)
•Advanced or unresectable RCC
•Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan
•No brain metastases
•Brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by CT scan or MRI, for ≥ 6 months are allowed
•PATIENT CHARACTERISTICS:
•ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
•Absolute neutrophil count ≥ 1,500/mm³
•Platelet count ≥ 100,000/mm³
•Creatinine ≤ 2.0 mg/dL
•Bilirubin ≤ 1.5 mg/dL
•AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception
•No other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer
•No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide
•No uncontrolled intercurrent illness including, but not limited to, any of the following:
•Ongoing or active infection
•Symptomatic congestive heart failure
•Unstable angina pectoris
•Cardiac arrhythmia
•Psychiatric illness or social situation that would limit study compliance
•No hepatitis A, B, or C positivity
•No HIV positivity
•PRIOR CONCURRENT THERAPY:
•See Disease Characteristics
•No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy, immunotherapy)
•At least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered
•No prior lenalidomide
•No other concurrent anticancer agents or treatments
•No other concurrent investigational agents
•No concurrent sargramostim (GM-CSF), radiotherapy, or thalidomide

排除标准

未提供

研究组 & 干预措施

Lenalidomide for Advanced RCC

Experimental

25 mg/day Lenalidomide for 21 days per cycle.

干预措施: lenalidomide (Drug)

结局指标

主要结局

Overall response

Objective Response Rate

时间窗: Baseline and every 2 weeks until study completion, up to 1.5 years

The objective response rate was defined by RECIST.

次要结局

Toxicity
Toxicity--Most Common AEs(Baseline and every 2 weeks until study completion. Number of cycles is open ended.)
Overall Survival(1 to 16 cycles, until patient expires, is lost to follow up or withdraws consent)

研究者

发起方

The Cleveland Clinic

申办方类型

Other

责任方

Sponsor

研究点 (1)

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