Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009919
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2001-02-02
Brief Title:
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of SU5416 NSC 696819 for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
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:
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2 SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens
II Determine the changes in tumor perfusion in patients treated with this regimen
III Determine the time to progression and survival in patients treated with this regimen
OUTLINE
Patients receive SU5416 IV over 1 hour twice weekly Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive an additional 6 months of therapy after achieving CR
Patients are followed every 3 months
I Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens
II Determine the changes in tumor perfusion in patients treated with this regimen
III Determine the time to progression and survival in patients treated with this regimen
OUTLINE
Patients receive SU5416 IV over 1 hour twice weekly Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive an additional 6 months of therapy after achieving CR
Patients are followed every 3 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 |
|---|---|---|---|
| CDR0000068424 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| ID99-291 | None | None | None |
| N01CM17003 | NIH | None | None |