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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Interventions
Registration Number
NCT00403169
Lead Sponsor
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.

Detailed Description

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Lenalidomide for Advanced RCClenalidomide25 mg/day Lenalidomide for 21 days per cycle.
Primary Outcome Measures
NameTimeMethod
Overall response
Secondary Outcome Measures
NameTimeMethod
Toxicity

Trial Locations

Locations (1)

Case Comprehensive Cancer Center

🇺🇸

Cleveland, Ohio, United States

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