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Trial Testing Precision Medicine as Skin Cancer Therapy


(Arun Kulshreshtha, Wikimedia Commons)

18 June 2015. A clinical trial is recruiting participants to test targeted molecular therapies as treatments for advanced cases of skin cancer. The study plans to enroll 96 individuals with melanoma, an advanced and dangerous form of skin cancer, found spreading to other organs in the body and cannot be treated with surgery.

Melanoma results from genetic defects or mutations, often from excessive exposure to ultraviolet radiation from sunshine or tanning lights. The mutations cause tumors to develop in melanocytes, the cells giving skin its pigment, and spread rapidly. If not treated early, melanoma can metastasize, or spread to other parts of the body, and become fatal. Skin Cancer Foundation cites data showing some 135,000 new cases of melanoma are reported each year in the U.S., resulting in nearly 10,000 deaths.

The clinical trial is being conducted by a consortium funded by the organizations Stand Up to Cancer and Melanoma Research Alliance, and led by researchers from Yale University, Mayo Clinic, and Translational Genomics Research Institute in Phoenix. The study is testing therapies for people with melanoma who do not have a characteristic genetic mutation, a condition believed to affect about half of the population with the disease. Individuals with this specific mutation are candidates for therapies that harness the immune system to treat melanoma. Participants in the trial do not have this mutation, and thus generally have fewer treatment options.

In this study, the participants’ tumors will be genetically sequenced to determine their specific molecular construction. Participants then will be randomly assigned receive drugs designed to address the particular molecular make-up of the tumors, or the standard of care for the patient’s type and stage of melanoma. More than 20 different treatment options are expected to be tested in the trial. All participants will be monitored for 1 year.

“By leveraging the power of cancer genomics, we believe we can treat each patient with the best drug for their individual situation,” says Alan Bryce, one of the lead investigators, in a Mayo Clinic statement. “This design offers patients a huge advantage over the old model of treating all patients the same way and only testing one drug at a time.”

The trial is currently enrolling participants at Yale University’s cancer center in New Haven, Connecticut, as well as Mayo Clinic facilities in Scottsdale, Arizona and Jacksonville, Florida. Another 10 locations are expected to recruit patients as the study progresses.

The researchers will look primarily at the best overall response rate, a standard measure of overall change in the participants’ tumors. The study is also measuring progression free survival time of the patients, results of specific target-drug matchings, and safety of the therapies.

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