Mount Sinai Launches Phase III Clinical Trial of Novel, Personalized Vaccine for Newly-Diagnosed Kidney Cancer

Study will examine potential of investigational immunotherapy AGS-003 to improve survival when combined with standard kidney cancer treatment.

New York, NY
 – April 17, 2013 /Press Release/  –– 

The Icahn School of Medicine at Mount Sinai is the only academic medical center in New York City to initiate a Phase III clinical trial evaluating AGS-003, the first fully-personalized cancer immunotherapy for metastatic renal cell carcinoma (mRCC), a type of advanced kidney cancer.  For people with metastatic kidney cancer, there are limited treatment options. Average survival can be approximately six months to two years. There is a critical need for new therapies.

ADAPT (Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma) is a randomized, open-label multicenter clinical trial investigating the potential for AGS-003 plus standard targeted drug therapy to extend overall survival versus standard therapy alone. Michael Palese, MD, and Matthew Galsky, MD, are leading the trial at Mount Sinai.

“Metastatic kidney cancer is a devastating disease for which there are very few treatment options,” said Dr. Palese, Associate Professor of Urology at Mount Sinai. “Previous AGS-003 studies for this type of kidney cancer have shown encouraging results and we look forward to evaluating this promising new vaccine in a phase III trial.”

The ADAPT study is expected to enroll 450 newly-diagnosed mRCC patients at approximately 120 sites, mostly in North America. All participants will be treated for six weeks with sunitinib, the current standard of care for mRCC, prior to treatment initiation with AGS-003. Patients randomized to the combination arm will begin AGS-003 treatment at the conclusion of the first six-week cycle of sunitinib. These patients will receive at least eight doses of AGS-003 over the initial 12 months, followed by a booster injection every three months for those continuing to benefit after the first year of treatment. Patients receiving AGS-003 will be evaluated for overall survival, progression-free survival, overall response rate, immune response, and safety.

AGS-003 is a truly personalized treatment in that it is made from a patient’s own white blood and tumor cells. To develop the vaccine, RNA is isolated from a small sample of tumor tissue obtained from the patient’s kidney during a routine procedure and certain specialized white blood cells are taken from the patient during a blood draw a few weeks later. The tumor RNA is then used to “teach” the white blood cells how to recognize the patient’s specific cancer. These white blood cells are then formulated into a ready-to-use injection which triggers the patient’s immune system to attack the cancer.

“Combining targeted drug therapy with AGS-003, which is designed to trigger the body’s natural immune response to help recognize and kill cancer cells, is an exciting new treatment approach,” said Dr. Galsky, Associate Professor of Medicine in the Division of Hematology/Oncology at Mount Sinai.

In three previous clinical studies in mRCC, AGS-003 has been well tolerated by patients. Side-effects have been limited to mild to moderate injection site reactions, short-lived flu-like symptoms and tenderness in the lymph nodes, all of which are indicative of immune response activation and usually occur around the time of AGS-003 dosing.

To be considered for the ADAPT study patients must be 18 or older and newly diagnosed with clear cell mRCC. Patients must be good candidates for standard tumor removal surgery and for treatment with standard targeted drug therapy, starting with sunitinib.

If you are interested in participating in this investigational clinical study, please call the study coordinator, Lourdes Campos-Grundvig, at (212) 241-3141 or visit http://icahn.mssm.edu/research/clinical-trials/cancer-clinical-trials/adult-cancers/genitourinary/kidney/13-0476.

The Tisch Cancer Institute (TCI) is a world-class translational cancer institute established in December 2007. TCI has recruited more than 30 acclaimed physicians and researchers specializing in basic research, clinical research, and population science; built outstanding programs in solid tumor oncology; enhanced existing robust programs in hematological malignancies; and advanced the study of cancer immunology and vaccine therapy. The completion of the Leon and Norma Hess Center for Science and Medicine in 2012 is enabling the recruitment of up to 20 additional cancer researchers on two full research floors, with 48,000 square feet of space dedicated to cancer research.

The Tisch Cancer Institute’s Cancer Clinical Trials Office (CCTO) provides the infrastructure and resources required to support patient-based cancer research for the Tisch Cancer Institute at Mount Sinai. The CCTO serves as the central location for cancer protocols and provides a centralized database of protocol-specific data. The CCTO maintains a current list of active protocols and enrollments for use by disease teams and TCI management and reports on the status of open protocols.

About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai. Established in 1968, the Icahn School of Medicine at Mount Sinai is one of the leading medical schools in the United States. The Icahn School of Medicine is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty members in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.

The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation’s oldest, largest and most-respected voluntary hospitals. In 2012, U.S. News & World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nation’s top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of just 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and by U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll.  Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.

For more information, visit http://www.mountsinai.org.  
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