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Surgical oncologist Dr. Armando Sardi, Director, The Institute for Cancer Care, leads study at Mercy for drug for advanced melanoma.

Mercy Medical Center Only Hospital in Baltimore Metro area to Participate in Study Re: New Option For Advanced Melanoma

Baltimore-Area Residents with Stage 3 or Stage 4 Melanoma May Be Eligible to Participate in a Clinical Research Study Re: Allovectin-7®

(Baltimore, MD) — Noted surgical oncologist Dr. Armando Sardi, Director, The Institute for Cancer Care at Mercy Medical Center, and the medical team at the Institute have begun recruiting patients for a Phase 3 study to evaluate the safety and effectiveness of Allovectin-7®, an investigational product for advanced melanoma (Phase 3 studies are randomized controlled trials conducted at a number of centers involving large numbers of patients and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatments).

Currently, Mercy Medical Center is the only hospital in the Baltimore metropolitan region to participate in this study.

If Allovectin-7® is found to be safe and effective in clinical trials, it may offer patients a new option for fighting advanced stage 3 or stage 4 melanoma. 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.

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,” study investigator Dr. Sardi said. “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. Potential study participants can determine their eligibility by visiting www.melanomatrial.com.

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.