Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer

Recurrent Renal Cell Carcinoma Clinical Trial

Official title: Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer <pT2

Status Terminated

Clinical Trial Summary

This pilot clinical trial studies vaccine therapy before surgery in treating patients with kidney cancer that has not spread to nearby lymph nodes or to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells when they are infused back into the body.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal cell carcinoma.

SECONDARY OBJECTIVES:

I. To assess the feasibility that total tumor RNA processing-related activities meet specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor harvesting prior to nephrectomy.

OUTLINE:

Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected autologous dendritic cell vaccine AGS-003 intradermally (ID) once every 7 days during weeks 6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy on week 10.

After completion of study treatment, patients are followed up at 1 month. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Recurrent Renal Cell Carcinoma
• Stage I Renal Cell Cancer
• Stage II Renal Cell Cancer

• NCT number: NCT02170389
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Terminated
• Phase: N/A
• Start date: October 14, 2014
• Completion date: March 17, 2017