Melanoma specialists at Moores UCSD Cancer 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 melanoma that has progressed to 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 in Atlanta, Georgia.
The ongoing Phase 3 study, sponsored by Vical, a San Diego-based biopharmaceutical company, is designed to determine whether more patients with advanced melanoma respond favorably to Allovectin-7® alone than to current standard chemotherapy alone.
“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 study investigator Gregory A. Daniels, M.D., Ph.D., coordinator of the clinical program in melanoma at the Moores UCSD Cancer Center and assistant professor of clinical medicine, University of California, San Diego, School of Medicine.
“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.”
“Most treatments involve a balance between quality of life and palliation of symptoms,” noted Daniels. “The tolerance level for Allovectin-7® is outstanding. The treatment involves a weekly injection, delivered in an outpatient setting, that only takes a few minutes then the patient goes home. This is a relatively easy treatment which also provides a chance to change the course of the disease.”
Allovectin-7® has been previously administered to over 700 cancer patients in several multi-center clinical trials.
In the current trial, 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.
Patients eligible for the current Allovectin-7® clinical trial 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). Those who have already received chemotherapy for melanoma are not eligible. In addition, patients with lung lesions can be included but those with liver or brain lesions cannot.