Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096525
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2004-11-09
Brief Title:
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
Status:
COMPLETED
Status Verified Date:
2013-01
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 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
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
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
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04014 | None | None | None |