NEW YORKIn patients with metastatic cutaneous melanoma who have already failed or are refractory to standard treatment, Allovectin-7, a targeted gene therapy using a nonviral delivery system, can induce both local and systemic responses in tumors injected weekly, results of a multicenter phase II study suggest.
The overall response rate was 14% for evaluable patients, all of whom had stage III or IV disease and had received one or more doses of the treatment. Overall response rate among the intent-to-treat population (77 patients) was about 10%, Ronald Blum, MD, reported at a late-breaking developments session at the Chemotherapy Foundation Symposium XIX.
The toxicity profile for Allovec-tin-7 was "excellent," said Dr. Blum, director of the Cancer Center at Beth Israel Medical Center, New York.
Allovectin-7 is a DNA/lipid complex that contains the human gene encoding HLA-B7 and beta-2 microglobulin, both of which are thought to be downregulated in a number of melanoma patients. The complex is designed to be injected into malignant tumors, which absorb it and express the HLA-B7 antigen.
"The excellent toxicity profile, the ease of manufacture, and routine treatment administration suggest that Allovectin-7 may offer advantages over current modalities of therapy in select subsets of patients," Dr. Blum said.
The phase II study included 78 patients with refractory or relapsed stage III or IV melanoma. The lipid/DNA complex was administered by intratumoral injection into a single tumor lesion weekly for 6 weeks, followed by a 4-week "hiatus" for observation. Additional 10-week treatment cycles (6 weeks injection, 4 weeks hiatus) could continue for patients who were stable or responding.