LITTLE ROCK – Skin cancer specialists at the University of Arkansas for Medical Sciences’ (UAMS) Winthrop P. Rockefeller Cancer Institute (formerly the Arkansas Cancer Research 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.
“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 Laura Hutchins, M.D., of UAMS’ Winthrop P. Rockefeller Cancer Institute, an investigator on the Allovectin-7® study. Hutchins also is a professor, director of the UAMS Division of Hematology/Oncology and director of clinical research for the Cancer Institute. “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.”
Melanoma is among the fastest-growing cancer indications, rising at a 3 percent 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
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.
Allovectin-7® has been previously administered to more than 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.
UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, six centers of excellence and a statewide network of regional centers. UAMS has about 2,538 students and 733 medical residents. It is one of the state’s largest public employers with about 9,600 employees, including nearly 1,000 physicians who provide medical care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS’
UAMS is the state’s only comprehensive academic health center, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a northwest Arkansas regional campus; a statewide network of regional centers; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute, the Donald W. Reynolds Institute on Aging and the Translational Research Institute. It is the only adult Level 1 trauma center in the state. UAMS has 3,021 students, 789 medical residents and two dental residents. It is the state’s largest public employer with more than 10,000 employees, including about 1,000 physicians and other professionals who provide care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS regional centers throughout the state. Visit www.uams.edu or www.uamshealth.com. Find us on Facebook, Twitter, YouTube or Instagram.