Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer

Completed · Phase 1/Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell Immunotherapeutic to patients with newly diagnosed with metastatic kidney cancer

Key facts

Study ID

NCT00272649

Run by

Argos Therapeutics

People needed

22

Starts

2006-01-01

Expected to finish

2012-02-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a new diagnosis of metastatic renal cell carcinoma;
• Measurable disease
• Must be at least 18 years or older;
• Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
• ECOG of 0 or 1;
• Free of brain metastases by CT or MRI;
• Normal renal function in contralateral kidney;
• Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
• Clinically acceptable screening results.
• No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
• No active autoimmune disease

Where it is running

• UCLA Kidney Cancer Program — Los Angeles, California, United States
• Univ. of Colorado Health Science Center - Division of Medical Oncology — Aurora, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• The Indiana University Cancer Center/IUPUI — Indianapolis, Indiana, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Carolinas Medical Center/Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Earle A. Chiles Research Institute — Portland, Oregon, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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