Ignite Creation Date:
2024-05-05 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00582790
Status:
TERMINATED
Last Update Posted:
2019-11-25
First Post:
2007-12-19
Brief Title:
Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study In particular this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid
Detailed Description:
The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated unresectable metastatic renal cell carcinoma Also the study will assess the tolerability safety pharmacodynamic effects and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serumplasma angiogenicmetastatic factor levels and by quantitating changes in cytokine expression antigen-specific T-cell immune responses and peripheral gd T-cell frequency and function
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 |
|---|---|---|---|
| SMPHMEDICINEMEDICINEH | OTHER | UW Madison | None |
| CO03805 | None | None | None |
| A534260 | OTHER | None | None |