Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440973
Status:
TERMINATED
Last Update Posted:
2016-03-17
First Post:
2007-02-23
Brief Title:
Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
contract issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the combination of therapy to strengthen the immune system Interleukin - 2 plus a specific tumor target therapy Bevacizumab can prolong the time between the start of treatment and disease progression decrease tumor size as well as determine if the combination therapy is safer and less toxic than the standard treatment for renal cell carcinoma
Detailed Description:
The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses but associated with higher frequency of toxicities IL-2 given at lower doses have demonstrated similar results than higher doses but it requires further study RCC is highly vascular and expresses high levels of VEGF Bevacizumab is a monoclonal antibody directed against the Vascular Endothelial Growth Factor VEGF responsible for angiogenesis
The study is designed to evaluate a response defined as time to progression safety and toxicity in patients with metastatic renal cell carcinoma Tissue correlation to evaluate the impact of vascular VEGF on clinical outcome will be retrospectively performed
The study is designed to evaluate a response defined as time to progression safety and toxicity in patients with metastatic renal cell carcinoma Tissue correlation to evaluate the impact of vascular VEGF on clinical outcome will be retrospectively performed
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 |
|---|---|---|---|
| 16117 | OTHER | Principal Investigator | None |