Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00403169
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2006-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE-CCF-7165 | None | None | View |