Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006003
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-07-05
Brief Title:
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of SU5416 NSC 696819 in Patients With Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416
II Determine the toxicity of SU5416 in this patient population III Determine the median and overall survival and time to progression in these patients receiving this treatment
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL A total of 14-35 patients will be accrued for this study within 18-24 months
I Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416
II Determine the toxicity of SU5416 in this patient population III Determine the median and overall survival and time to progression in these patients receiving this treatment
OUTLINE This is a multicenter study
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL A total of 14-35 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| CDR0000068011 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| 10395 | None | None | None |
| N01CM17102 | NIH | None | None |