Melanoma trial

18 October 2007 — Skin cancer specialists at the Southeastern Medical Oncology Center are recruiting patients into a large Phase 3 study to evaluate the safety and effectiveness of Allovectin-7®, an investigational product for advanced melanoma. If Allovectin-7® is found to be safe and effective in clinical trials, it may offer patients a new option for fighting advanced melanoma (stage 3 or stage 4). Safety and efficacy data from a Phase 2 clinical trial of Allovectin-7® were presented at the 2006 American Society of Clinical Oncology (ASCO) meeting. The ongoing Phase 3 study is designed to determine whether more patients with advanced melanoma respond favorably to Allovectin-7® alone than to current standard chemotherapy alone. To find out whether you or someone you know qualifies for the study, please visit www.melanomatrial.com.

Melanoma is among the fastest-growing cancer indications, rising at a 3 to 5 percent annual rate during the last 30 years. The American Cancer Society estimates that in 2007 about 60,000 new cases of melanoma will be diagnosed in the United States and more than 8,000 patients will die from melanoma. The exact cause of melanoma is not always clear, but exposure to ultraviolet radiation from sunlight is a major risk factor. Melanoma is more likely to occur in those having fair skin, a large number of moles, a history of sun tanning or sunburns, or close relatives with the disease.

Patients whose melanoma is caught early can often be cured with surgery. However, more advanced stage 3 or 4 melanoma, which has spread beyond the original site to other parts of the body, usually requires additional medical intervention such as chemotherapy. Because cures at this stage are rare, therapy for late stage melanoma is focused on reducing the tumor burden and hopefully increasing a patient’s length of survival. Most patients who receive standard chemotherapy experience poor long-lasting response rates and serious side effects.

“Cancer cells often evade the body’s natural disease-fighting mechanisms. The challenge in treating advanced melanoma is to find a way to train the natural immune system to locate and eliminate cancerous cells,” said Dr. James Atkins of the Southeastern Medical Oncology Center, an investigator on the Allovectin-7® study. “We believe that Allovectin-7® triggers several of the body’s natural immune response mechanisms to recognize and attack the tumors, both locally and throughout the body. “

Allovectin-7® has been previously administered to over 700 cancer patients in several multi-center clinical trials.

To be eligible for the current Allovectin-7® clinical trial, patients must be at least 18 years old and have confirmed recurrent metastatic melanoma with at least one tumor large enough to inject − about the size of a pea. Patients having received previous chemotherapy for melanoma cannot participate. In addition, patients with lung lesions can be included but those with liver or brain lesions cannot.

Approximately 375 patients will be enrolled to receive either Allovectin-7® alone or the current standard chemotherapy (dacarbazine or temozolomide) alone. Sixty-seven percent of enrolled patients will be randomly assigned to receive Allovectin-7® and 33 percent will receive chemotherapy. Allovectin-7® will be administered by a weekly injection into the tumor for six consecutive weeks. The injection cycle may be repeated every eight weeks. Participants will be closely monitored to assess disease status, safety and tolerability. Patients whose melanoma does not clinically progress will be encouraged to continue on the trial and be assessed for up to two years.

Serving cancer and hematology patients in Eastern North Carolina since 1984, the Southeastern Medical Oncology Center combines compassion, dedication, experience, research, leading edge medicine, pain control and teamwork in the diagnosis and treatment of cancer and blood related diseases. Our nursing staff of specially-trained chemotherapy nurses is complemented with an in-house laboratory and social services. The entire team at Southeastern Medical Oncology Center works with patients, families and partnered healthcare providers to assure high quality treatment, therapy and care. The Center operates at three locations in Goldsboro, Clinton and Wilson.

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