Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00496756
Status:
TERMINATED
Last Update Posted:
2023-10-26
First Post:
2007-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
Sponsor:
University of Nebraska
Organization:
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 T4/T8, 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 T4/T8, 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA036727 | NIH | None | https://reporter.nih.gov/quic… | View |