Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT00006003
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
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 |
|---|---|---|---|---|
| 10395 | None | None | View | |
| N01CM17102 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000068011 | REGISTRY | PDQ (Physician Data Query) | View |