RNA-Loaded Dendritic Cell Cancer Vaccine

A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.

Inclusion Criteria:

• Have a new diagnosis of metastatic renal cell carcinoma;
• Must be at least 18 years or older;
• Have a scheduled unilateral nephrectomy;
• 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