Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006384
Status:
COMPLETED
Last Update Posted:
2011-10-20
First Post:
2000-10-04
Brief Title:
SU5416 and Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-10
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 SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor Interferon alfa-2b may interfere with the growth of the cancer cells Combining interferon alfa-2b with SU5416 may be an effective treatment for kidney cancer
PURPOSE Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b in treating patients who have unresectable or metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b in treating patients who have unresectable or metastatic kidney cancer
Detailed Description:
OBJECTIVES I Determine the efficacy and toxicity of SU5416 combined with interferon alfa-2b in patients with unresectable or metastatic renal cell carcinoma
OUTLINE This is a multicenter study Patients receive SU5416 IV over 30-60 minutes twice weekly and interferon alfa-2b subcutaneously every 12 hours daily Treatment continues every 6 weeks for a minimum of 2 courses Patients who achieve partial response or stable disease after completion of course 2 receive additional courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response may receive additional courses at the discretion of the protocol investigator in the absence of disease progression or unacceptable toxicity Patients with disease progression are allowed to stay on the study until any measurable lesion increases to over 100 of baseline measurement Patients are followed for survival
PROJECTED ACCRUAL A total of 20-31 patients will be accrued for this study within 12-18 months
OUTLINE This is a multicenter study Patients receive SU5416 IV over 30-60 minutes twice weekly and interferon alfa-2b subcutaneously every 12 hours daily Treatment continues every 6 weeks for a minimum of 2 courses Patients who achieve partial response or stable disease after completion of course 2 receive additional courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete response may receive additional courses at the discretion of the protocol investigator in the absence of disease progression or unacceptable toxicity Patients with disease progression are allowed to stay on the study until any measurable lesion increases to over 100 of baseline measurement Patients are followed for survival
PROJECTED ACCRUAL A total of 20-31 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| U01CA062505 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHII-23 | None | None | None |
| NCI-T99-0085 | None | None | None |
| CDR0000068262 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |