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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Registration Number
NCT00096525
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy (complete and partial response)
Secondary Outcome Measures
NameTimeMethod
Toxicity
Adverse events

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

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