Moores Cancer Center Initiates Phase III Study of Melanoma Drug
Posted on: Thursday, 13 December 2007, 06:00 CST
Moores UCSD Cancer Center has started recruiting patients into a large Phase III study to evaluate the safety and effectiveness of Allovectin-7, an investigational product for advanced melanoma.
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. In all, 67% of enrolled patients will be randomly assigned to receive Allovectin-7 and 33% 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.
The ongoing Phase III 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. 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.
Gregory Daniels, coordinator of the clinical program in melanoma at the Moores UCSD Cancer Center, 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."
Source: Datamonitor
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