Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462982
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2007-04-18
Brief Title:
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of SU11248 Sunitinib in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain
Status:
COMPLETED
Status Verified Date:
2015-11
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 Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of sunitinib malate in terms of objective radiographic response of brain lesions in patients with brain metastases secondary to renal cell carcinoma or melanoma
Secondary
Determine overall and progression-free survival
OUTLINE Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
Primary
Determine the efficacy of sunitinib malate in terms of objective radiographic response of brain lesions in patients with brain metastases secondary to renal cell carcinoma or melanoma
Secondary
Determine overall and progression-free survival
OUTLINE Patients receive oral sunitinib malate once daily on days 1-28 Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| MSKCC-07009 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |