Renal (Kidney) Cancer Trial at CORT: Immunotherapy and Sunitinib

From http://cancernews.wordpress.com/2008/06/06/renal-kidney-cancer-trial-at-cort-immunotherapy-and-sunitinib/

Renal (Kidney) Cancer Trial at CORT: Immunotherapy and Sunitinib

CORT has opened the Phase II Argos Therapeutics trial of RNA-loaded autologous dendritic cell (DC)immunotherapy combined with standard sunitinib (Sutent) therapy for metastatic renal cell carcinoma (kidney cancer). This study is open to newly diagnosed patients with Stage IV (metastatic) disease. The trial employs Argos’ platform of enhanced DC technology to stimulate patient-specific immune response in a personalized DC preparation. After consent and enrollment, the patient will undergo standard nephrectomy (removal of the cancerous kidney). I a separate procedure, blood cells are collected by leukapheresis, a short procedure which removes circulating DC from the blood by the use of a machine. Tissue from the tumor and the collected DC are processed by Argos to create DC that contain a DC product specific to the patient-specific tumor proteins. After recovery from the surgery, the patient will receive standard sunitinib (Sutent) oral drug therapy and infusions of the personalized tumor DC product. The outcomes of therapy (safety, responses, disease control, survival) will be followed. Earlier phase studies have demonstrated safety of the Argos DC therapy.

Unique advantages of a personalized, patient-specific immunotherapy include:

Dendritic cells transfected with RNA-encoding tumor antigens have been shown to stimulate potent immune cell responses equal or superior to other competing approaches

The immunotherapeutic is completely autologous (derived from the patient’s body), potentially offering maximum safety with minimal side effects

The immunotherapeutic targets the entire antigenic repertoire of the tumor including ‘private mutations’ unique to that patient

A single production run makes enough product to continuously treat the patient for several years

Production requires only a minute tumor specimen

Because it is important to be enrolled in the study prior to surgery, interested patients should seek referral at CORT for consultation PRIOR to surgery, so tumor tissue that is obtained at the time of surgery can be utilized in preparation of the individual DC product.

For more information about this study, contact one of our Research Coordinators at trials@cortpa.com or call 972-566-5588. Information about CORT and this study is also available at www.CORTPA.com.