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CompletedNCT00096525Updated Jan 17, 2013

Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

A Phase 2 interventional study of lenalidomide in Kidney Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-17.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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.

02

Conditions studied

  • Kidney Cancer

Keywords

  • recurrent renal cell cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

Browse Kidney Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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:

Age

  • 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

Hepatic

  • 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

Renal

  • Creatinine ≤ 2.0 mg/dL

Other

  • 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

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered

Other

  • No more than 1 other prior systemic therapy regimen for RCC
  • No other concurrent anticancer therapies
  • No other concurrent investigational agents
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Druglenalidomide
06

What researchers measure

Primary outcomes

  1. Efficacy (complete and partial response)

Secondary outcomes

  1. Toxicity

  2. Adverse events

07

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
08

References and documents

Publications

  • 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. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27. PubMed 18161005 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00096525
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
First posted
Nov 10, 2004
Start date
Jul 2004
Primary completion
Aug 2005
Last update
Jan 17, 2013

Study contacts

Gnanamba V. Kondagunta, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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