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Madison, Wisconsin 53792


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed renal cell carcinoma with metastasis. - Must have measurable disease. - No prior cytokine, chemotherapy, hormonal, or other immuno-based therapies (including vaccine or cellular based) for their renal cancer is allowed. No prior use of bisphosphonates will be allowed. One prior experimental therapy will be permitted as long as > 4 weeks have passed since last drug administration. - ECOG performance status 0 or 1 - Adequate cardiac function by history. - Pulse-oximetry > 92% on room air. Exclusion Criteria: - Radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. - Known brain metastases - Any history of an autoimmune disease (ie. psoriasis, inflammatory bowel disease, etc) must receive clearance by the investigator before being permitted on study due to the potential worsening of those disorders from IL- - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. - History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment. - History of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent and disease free for > 5 years. - Any history of seizures given increased seizure risk with IL-2. - Organ allograft (transplant) recipients will be excluded given absolute contraindication with IL-2 therapy. - Pregnant women are excluded - Patients on systemic steroids (oral or IV) will not be eligible for the study.


NCT ID:

NCT00582790


Primary Contact:

Principal Investigator
Glenn Liu, MD
University of Wisconsin, Madison


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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