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2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 10:49 AM
Study NCT ID:
NCT00126594
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-07
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:
This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC.
II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC.
SECONDARY OBJECTIVES:
I. Progression free survival. II. Duration of response. III. Overall Survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral sorafenib twice daily on days 1-28.
Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.
Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.
After completion of study treatment, patients are followed every 3 months.
I. Efficacy of Bay 43-9006 with or without low dose interferon by evaluating response rate in MRCC.
II. Toxicities of Bay 43-9006 with or without low dose interferon in MRCC.
SECONDARY OBJECTIVES:
I. Progression free survival. II. Duration of response. III. Overall Survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral sorafenib twice daily on days 1-28.
Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.
Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.
After completion of study treatment, patients are followed every 3 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 |
|---|---|---|---|---|
| NCI-2012-02910 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000437796 | None | None | View | |
| 2004-0526 | OTHER | M D Anderson Cancer Center | View | |
| 6629 | OTHER | CTEP | View | |
| N01CM62202 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |