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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403169
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : April 20, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: lenalidomide Phase 2

Detailed Description:


  • 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.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)
Study Start Date : August 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Lenalidomide for Advanced RCC
25 mg/day Lenalidomide for 21 days per cycle.
Drug: lenalidomide
Other Name: CC-5013

Primary Outcome Measures :
  1. Overall response

Secondary Outcome Measures :
  1. Toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403169

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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
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Study Chair: Robert Dreicer, MD, FACP Case Comprehensive Cancer Center
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Responsible Party: The Cleveland Clinic Identifier: NCT00403169    
Other Study ID Numbers: CASE-CCF-7165
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by The Cleveland Clinic:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents