Public Release: 

CTCA at Western Regional Medical Center launches Phase II of PembroPlus clinical trial

First-of-its-kind immunotherapy study targets patients with advanced-stage cancers

Cancer Treatment Centers of America

(Goodyear, Arizona - April 27, 2015) - Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun the Phase II portion of the first of six arms of this first-of-its-kind clinical trial, using a new immunotherapy treatment for patients with advanced small cell lung cancer, pancreatic cancer and connective-tissue cancers, including breast cancer.

This innovative "PembroPlus" clinical trial combines an immunotherapy drug (pembrolizumab) with already FDA-approved chemotherapy drugs (gemcitabine, docetaxel, nab-paclitaxel, vinorelbine, irinotecan, and/or liposomal doxorubicin). The addition of pembrolizumab is aimed at activating the body's own immune system to improve the results that otherwise might be achieved from chemotherapy alone. This combination of chemotherapy drugs is investigational in this study.

A patient with advanced-stage triple negative breast cancer received the first Phase II treatment on April 23. Triple negative breast cancer is one of the most aggressive and difficult to treat of all breast cancers.

The term triple negative refers to the fact that this type of cancer tests negative for estrogen receptors, progesterone receptors and the HER2 protein, and therefore does not respond to hormonal therapy or therapies that target HER2 receptors. Studies have shown that triple-negative breast cancer is more likely to spread beyond the breast and more likely to recur after initial treatment.

The study will enroll up to 140 patients who have exhausted previous standard-of-care treatments and are now eligible for clinical trial studies. It includes patients with advanced small cell lung cancer, pancreatic cancer, breast cancer, and a variety of sarcomas, which are cancers of the body's connective tissues, including muscles, fat, nerves and bones.

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 this study, initiated in January 2015, pembrolizumab with gemcitabine was successfully 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 this combination to a larger group of patients with triple negative breast cancer to see if it is effective and to further evaluate its safety.

"Patients in this study have advanced-stage cancers that are difficult to treat," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and PembroPlus Principal Investigator. "We are investigating whether adding a drug that will stimulate the patients' own immune systems to the conventional chemotherapy drugs that are used in their type of cancer could be a more powerful approach against their disease."

Recent data reported in the New England Journal of Medicine1 and Lancet2 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. PembroPlus will build upon this data, extending treatment options to additional cancer types.

"We are using this combination therapy on cancer types not being targeted elsewhere, providing new treatment options for CTCA patients fighting advanced-stage cancers," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "We hope that we can improve on results observed with immunotherapy or chemotherapy treatment alone."

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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.

About Cancer Treatment Centers of America®

Cancer Treatment Centers of America, Inc. (CTCA) is a national network of five hospitals that specialize in the treatment of patients fighting complex cancer. CTCA offers an integrative approach to cancer treatment that combines surgery, radiation, and chemotherapy with nutritional counseling, naturopathic medicine, mind-body therapy, and spiritual support to enhance quality of life and minimize side effects during treatment. The company serves patients from all 50 states at hospitals located in Atlanta, Chicago, Philadelphia, Phoenix and Tulsa. Known for delivering the Mother Standard® of care and Patient Empowerment Medicine®, CTCA provides patients with comprehensive information about their treatment options so they can participate in their treatment decisions. For more information about CTCA, go to http://www.cancercenter.com.

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