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Yale-New Haven Hospital
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06510-3202
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March 2007
News this month Yale Cancer Center is participating in a clinical trial to test the effect of a new oral cancer drug to slow the growth of advanced melanoma. The study, officially called "A Double-Blind, Randomized, Placebo-controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma," is being run in conjunction with the National Cancer Institute, with funding from the National Institutes of Health. Harriet Kluger, MD, assistant professor of medicine, Yale Cancer Center, is the principal investigator for Yale for the clinical trial, coordinated by the Eastern Cooperative Oncology Group (ECOG), one of the largest clinical cancer research organizations in the country. “Patients in the study have
stage III and stage IV
melanoma that can’t be
cured with surgery.”
The study began in July 2005 and is under way at about 30 sites throughout the country. It tests whether a combination of two chemotherapy drugs and an oral drug can help slow the growth of melanoma. About 30 patients will participate at the Yale site, according to Dr. Kluger. Other patients in Connecticut are being enrolled at Manchester Memorial Hospital. The hope is that an oral drug, Sorafenib (BAY43-9006), might inhibit a protein, found in some melanomas, that encourages the tumor to grow. It also blocks the blood supply to tumors, slowing the rate of growth. Sorafenib is being given with two chemotherapy drugs, Paclitaxel and Carboplatin, and so far it is having a good response. The study is looking to see if the combination of the drugs works better than Paclitaxel and Carboplatin alone. The drugs are thought to work on a mutation in the BRAF gene that is often found in melanoma tumors. Patients in the study have stage III and stage IV melanoma that can’t be cured with surgery. Patients also can’t have untreated brain metastases or received previous chemotherapy. They must have a melanoma that can be detected on a CT scan. In 2002, scientists noted that the BRAF gene is mutated in most melanomas and is likely to be associated with disease progression. This may open the door for studies like this Phase III trial that use drugs that target BRAF to slow tumor growth. “In addition to being the lead
investigator, Dr. Kluger is
collecting samples from
tumors at all sites to see
whether the specimens have
the mutated BRAF gene.”
Patients are randomly assigned to one of two treatment groups. Group 1 receives a three-hour infusion of Paclitaxel and Carboplatin. These patients also receive Sorafenib orally twice a day for 19 days. Patients in Group 2 get the same infusion of Paclitaxel and Carboplatin, but instead of Sorafenib, they receive a placebo. Treatment is given every three weeks for up to 30 weeks. Patients are being evaluated every 6-12 weeks for two years to monitor their response. In addition to being the lead investigator, Dr. Kluger is collecting samples from tumors at all sites to see whether the specimens have the mutated BRAF gene. Dr. Kluger is using new technology called Automated Quantitative Analysis or AQUA, to assess these specimens. AQUA was developed at the Yale University School of Medicine by David Rimm, MD, PhD, associate professor of pathology and director of the Yale Cancer Center Tissue Microarray Facility; and Robert Camp, MD, PhD, associate research scientist in pathology. The technology uses dedicated software to analyze tissue, and with it, the team hopes to develop a test that can routinely be used on clinical specimens in an unbiased, automated fashion.
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 Might we be able to control advanced melanoma? Studies like these mean that we’re improving our understanding of the genetics, immunology and biology of melanoma, one of the most horrendous types of cancers. From some recent discoveries – like the recognition that 70 percent of melanoma tumors contain a mutant BRAF gene – we’re beginning to provide new treatments that we hope can save lives. “Melanoma has the highest
rate of increase of all the
cancers. The incidence has
doubled every decade since
1950, despite all the public
awareness of protecting
one’s skin against the sun.”
Melanoma has the highest rate of increase of all the cancers. The incidence has doubled every decade since 1950, despite all the public awareness of protecting one’s skin against the sun. In 2006 alone, more than 62,000 new cases were diagnosed, 7,000 of which were metastasized beyond the skin. Melanoma is a particularly deadly type of cancer because it easily metastasizes to the brain, lung and liver, making it very difficult to treat. It is clear that melanoma is a major public health issue, and I’m thrilled to be the lead investigator for Yale on this study. It is one of six studies on melanoma being conducted at Yale, and it signals the beginning of many more to come. Using the breast cancer paradigm, we hope to take steps to control melanoma like we have with breast cancer. The drug Sorafenib (BAY 43-9006) was thought to inhibit the RAF family of proteins and block the blood supply that allowed tumors to grow. It was like a stop sign for tumor growth. Doctors at the University of Pennsylvania first tried Sorafenib on patients with advanced melanoma. Given in combination with two established chemotherapy drugs (Carboplatin and Paclitaxel), Sorafenib had a good response. The tumors shrunk and stayed small. With this good a response, ECOG was encouraged to open the trial in 2005. While the study is ongoing, we are seeing responses. Our trial is designed to evaluate whether a new oral cancer medicine, Sorafenib or Nexavar®, helps chemotherapy work better in patients with advanced melanoma. Sorafenib acts by killing cancer cells in a different way than chemotherapy. All patients will receive the two chemotherapy medicines, Carboplatin and Paclitaxel. Patients are also randomly assigned to receive Sorafenib or a placebo pill. In addition, I’m collecting specimens of tumors from patients with melanoma from around the country to see if they contain the mutated BRAF gene. Together with my Yale colleagues and external collaborators, we’re seeing if we can identify tumor characteristics associated with response to therapy. In conclusion, we all need to be aware that everyone is at risk for skin cancer. However, some people have a genetic predisposition to the disease. Those people at higher risk include individuals with blue, gray or green eyes; fair skin who burn more easily; light hair; and a previous skin cancer or family history of skin cancer. Also, people who had blistering sun burns at a young age are at a higher risk. Many of the baby-boomers are now seeing signs of skin cancer because as young children, awareness of the importance of sun avoidance wasn’t prominent. The key to treatment, however, is early diagnosis. Be sure to visit your doctor yearly for a screening, especially for moles that have changed in shape, size or color. Prevention starts with awareness and use of a daily sunscreen when it’s necessary to be out in the sun. Dr. Kluger is assistant professor of medicine, medical oncology, for Yale University School of Medicine.  Yale-New Haven was recognized this year by U.S. News & World Report for its cancer services.
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