Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma
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
serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine
expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and
function.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid
Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
CT scans obtained at baseline, then every 2 cycles
No
Glenn Liu, MD
Principal Investigator
University of Wisconsin, Madison
United States: Institutional Review Board
HSC 2003-170
NCT00582790
August 2003
September 2008
Name | Location |
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University of Wisconsin | Madison,, Wisconsin 53792-5666 |