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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00096525
Recruitment Status : Completed
First Posted : November 10, 2004
Last Update Posted : January 17, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

November 9, 2004
November 10, 2004
January 17, 2013
July 2004
August 2005   (Final data collection date for primary outcome measure)
Efficacy (complete and partial response)
Not Provided
Complete list of historical versions of study NCT00096525 on ClinicalTrials.gov Archive Site
  • Toxicity
  • Adverse events
Not Provided
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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen

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.



  • 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.


  • Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Cancer
Drug: lenalidomide
Not Provided
Patel PH, Kondagunta GV, Schwartz L, Ishill N, Bacik J, DeLuca J, Russo P, Motzer RJ. Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs. 2008 Jun;26(3):273-6. Epub 2007 Dec 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
Not Provided
August 2005   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • 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


Biologic therapy

  • No more than 1 prior systemic immunotherapy regimen for RCC
  • No prior lenalidomide (CC-5013)
  • No prior or concurrent thalidomide


  • No more than 1 prior systemic chemotherapy regimen for RCC

Endocrine therapy

  • No more than 1 prior systemic hormonal therapy regimen for RCC


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP