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Protocol No. 2012IS062 Principal Investigator Jha, Gautam
Phase Phase III (Cancer Control)
Age Group Adult Scope National
Secondary Protocol No. AGS-003-007
Title An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Objective The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
Treatment Experimental: AGS-003 + Standard Treatment Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003. Active Comparator: Standard Treatment Subjects on this arm will receive standard treatment for Renal Cell Carcinoma
Description This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma.
Key Eligibility Patient must have a diagnosis or clinical signs of advanced RCC as defined by TNM classification of [any T, any N, M1].
Applicable Disease Sites Kidney
Therapies Involved Cell Cycle Inhibitor
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Patient must be at least 18 years of age and scheduled for unilateral or partial nephrectomy. Anyone with known brain metastases prior to nephrectomy or has a requirement for systemic chronic immunosuppressive drugs or corticosteroids is not eligible. Women who are pregnant or nursing are not eligible for treatment study. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
Contact Klaudija Dragicevic Phone:612-626-4495
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