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
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
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