Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482911
Status:
TERMINATED
Last Update Posted:
2017-03-27
First Post:
2007-06-04
Brief Title:
Lenalidomide Sunitinib and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Combination Oral CC-5013 Lenalidomide Revlimid Oral Sunitinib Sutent and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left the institute
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 tumor cells by blocking blood flow to the tumor Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving lenalidomide together with sunitinib and low doses of cyclophosphamide once a day may kill more tumor cells
PURPOSE This phase II trial is studying how well giving lenalidomide together with sunitinib and cyclophosphamide works in treating patients with stage IV eye melanoma
PURPOSE This phase II trial is studying how well giving lenalidomide together with sunitinib and cyclophosphamide works in treating patients with stage IV eye melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with stage IV ocular melanoma treated with lenalidomide sunitinib malate and low-dose metronomic cyclophosphamide
Secondary
Determine the toxicity of this regimen in these patients
Determine the progression-free survival of patients treated with this regimen
Obtain blood urine and tissue samples from these patients when easily accessible to determine the effects of this regimen on pathways thought to have been modulated by this regimen in pre-clinical studies
OUTLINE This is nonrandomized uncontrolled open-label study
Patients receive oral lenalidomide oral sunitinib malate and oral low-dose cyclophosphamide once daily on days 1-28 Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
NOTE Some patients will not receive sunitinib malate during course 1
After completion of study treatment patients are followed every 3 months for 2 years every 4 months for 3 years and then annually thereafter
Primary
Determine the response rate in patients with stage IV ocular melanoma treated with lenalidomide sunitinib malate and low-dose metronomic cyclophosphamide
Secondary
Determine the toxicity of this regimen in these patients
Determine the progression-free survival of patients treated with this regimen
Obtain blood urine and tissue samples from these patients when easily accessible to determine the effects of this regimen on pathways thought to have been modulated by this regimen in pre-clinical studies
OUTLINE This is nonrandomized uncontrolled open-label study
Patients receive oral lenalidomide oral sunitinib malate and oral low-dose cyclophosphamide once daily on days 1-28 Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
NOTE Some patients will not receive sunitinib malate during course 1
After completion of study treatment patients are followed every 3 months for 2 years every 4 months for 3 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-07-C-0134 | None | None | None |