University of Illinois at Chicago researchers are participating in a multi-center research trial to evaluate the safety and effectiveness of Allovectin-7, an investigational treatment for advanced melanoma.
Allovectin-7 is a gene-based immunotherapy for certain types of cancer. The therapy is designed to train the body's immune system to recognize and destroy tumor cells. The phase 3 study will determine if Allovectin-7 is more effective than standard chemotherapy for treating people with advanced melanoma.
"Melanoma, like many types of cancer, is often successful at keeping the body from attacking it," said Dr. Michael Warso, associate professor of surgical oncology at UIC and an investigator on the study. "One of the goals of treatment is to change things so the body can identify and attack the melanoma. 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."
To be eligible for the study, 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 who have received previous chemotherapy for melanoma are ineligible. In addition, patients with lung lesions can be included, but those with liver or brain lesions cannot.
Approximately 375 patients nationwide will be enrolled to receive either Allovectin-7 alone or the current standard chemotherapy (dacarbazine or temozolomide) alone. Two thirds of enrolled patients will be randomly assigned to receive Allovectin-7 and the remaining third 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, treatment safety and tolerability. Patients whose melanoma does not worsen will be encouraged to continue on the treatment and be assessed for up to two years.
Warso said the investigational agent can be given on an outpatient basis and has been safe and well-tolerated in clinical trials to date.