Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496756
Status:
TERMINATED
Last Update Posted:
2023-10-26
First Post:
2007-07-03
Brief Title:
Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer
PURPOSE This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma
Secondary
Determine tumor response in these patients
Determine time to progression in these patients
Determine overall survival of these patients
Tertiary
Collect data on angiogenesis inhibition induced by sorafenib tosylate
Collect data on immunomodulatory effects of sorafenib tosylate
OUTLINE This is an open-label study
Patients receive oral sorafenib tosylate twice daily on days 1-28 Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients receive escalating doses of sorafenib tosylate in the absence of grade 3 or 4 dose-limiting toxicity until a pre-determined dose is reached
Blood and urine samples are collected at baseline and periodically during study for VEGF level determination Blood samples are analyzed for T4T8 NK CD25 and Fox p3 by flow cytometry Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF
Primary
Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma
Secondary
Determine tumor response in these patients
Determine time to progression in these patients
Determine overall survival of these patients
Tertiary
Collect data on angiogenesis inhibition induced by sorafenib tosylate
Collect data on immunomodulatory effects of sorafenib tosylate
OUTLINE This is an open-label study
Patients receive oral sorafenib tosylate twice daily on days 1-28 Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients receive escalating doses of sorafenib tosylate in the absence of grade 3 or 4 dose-limiting toxicity until a pre-determined dose is reached
Blood and urine samples are collected at baseline and periodically during study for VEGF level determination Blood samples are analyzed for T4T8 NK CD25 and Fox p3 by flow cytometry Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P30CA036727 | NIH | None | httpsreporternihgovquickSearchP30CA036727 |