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CTCA at Western launches immunotherapy clinical trial aimed at soft-tissue cancers

New arm of innovative 'PembroPlus' clinical trial targets sarcomas

Cancer Treatment Centers of America

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IMAGE: This is Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. view more

Credit: Photo courtesy of CTCA

(Goodyear, Arizona - Sept. 17, 2015) - Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun Phase II of another arm of its multi-arm clinical trial that combines immunotherapy with chemotherapy.

This arm was specifically designed to target soft-tissue cancers known as sarcomas. This multifaceted study evaluating novel combination therapies known as "PembroPlus" is named for the immunotherapy compound pembrolizumab.

Using pembrolizumab, investigators at CTCA® Western intend to attempt to activate the body's own immune system to combat sarcomas to test whether such activation can improved results over those that would otherwise be achieved from chemotherapy alone.

"There is growing evidence that the use of immunotherapies like those in our PembroPlus clinical trials could enhance the ability to fight cancers," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "We will be testing this new arm for sarcoma patients to determine its effectiveness and safety."

This study will enroll as many as 140 patients who have received previous standard-of-care treatments and are now eligible for clinical trial studies. The first patient on the phase II portion of this arm received treatment today.

For this arm of the PembroPlus clinical trial, pembrolizumab is combined with liposomal doxorubicin, a chemotherapy previously used to successfully to treat AIDS-related Kaposi's sarcoma, breast cancer, ovarian cancer and other solid tumors. This combination of immunotherapy and chemotherapy drugs is investigational in this study.

Other arms and phases of the PembroPlus immunotherapy clinical trials employ pembrolizumab and other combinations of FDA-approved chemotherapy drugs to treat patients with advanced small cell lung cancer, pancreatic cancer, breast cancer and other advanced cancer types.

A sarcoma is a rare type of cancer that occurs in the body's connective tissue -- cells that connect or support other kinds of tissue in your body. These tumors are most common in bones, muscles, tendons, cartilage, nerves, fat and blood vessels, and are usually in the arms and legs but can appear anywhere.

Although there are more than 50 types of sarcoma, they can be grouped into two main kinds: soft tissue sarcoma and bone sarcoma, also known as osteosarcoma. About one percent of adult cases of cancer are soft tissue sarcoma. Osteosarcomas are even more rare.

Soft tissue sarcomas often go undiagnosed at first because there is no early-detection test. Usually, the first sign is a painless lump. As it grows, it may press against nerves or muscles, causing discomfort or pain.

"Each year, nearly 14,000 Americans are newly diagnosed with some form of sarcoma, which are often difficult to treat, especially in advanced stages," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and PembroPlus Principal Investigator. "We believe that, even though these types of cancer pose a significant challenge, researchers are developing powerful new tools that eventually may give cancer patients additional answers and renewed hope."

As with other CTCA care programs, PembroPlus embraces a Patient Empowered Care® model. This integrated care model places CTCA patients at the center of a comprehensive care team that includes both clinical and supportive therapies.

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For more information or to enroll in the PembroPlus clinical trial, or other CTCA trials, email westerntrials@ctca-hope.com or call 888-841-9129.

In Phase I of the PembroPlus study, initiated in January 2015, pembrolizumab was administered to a small group of patients to evaluate its safety, determine safe dosage and identify and side effects. Phase II of the study now enables CTCA researchers to administer combinations of immunotherapy and chemotherapy to a larger group of patients.

Recent data reported in the New England Journal of Medicine(1) and Lancet(2) demonstrates promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, and non-small cell lung cancer. Data has also shown synergetic effects of utilizing cytotoxic chemotherapy in combination with immunostimulatory therapy (http://ow.ly/FKHXi). PembroPlus will build upon this data, extending treatment options to additional cancer types.

References:

1. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012; 366(26):2443-54.?

2. Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014; 384(9948):1109-17.

For more information about the PembroPlus clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT02331251

About Cancer Treatment Centers of America

Cancer Treatment Centers of America® (CTCA), headquartered in Boca Raton, Fla., is a national network of five hospitals that serves adult patients who are fighting cancer. CTCA® offers an integrative approach to care that combines advancements in genomic testing and precision cancer treatment, surgery, radiation, immunotherapy and chemotherapy, with evidence-based complementary therapies that support patients physically and emotionally, enhancing their quality of life while reducing side effects both during and after treatment. CTCA serves patients from around the world at its hospitals in Atlanta, Chicago, Philadelphia, Phoenix and Tulsa. Consistently rated among U.S. hospitals that deliver the highest quality of care and patient experience, CTCA provides patients and their families with comprehensive information about their treatment options and encourages their active participation in treatment decisions. For more information, visit cancercenter.com, Facebook.com/cancercenter and Twitter.com/cancercenter.

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