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Clinical and Immunologic Responses to Gene Transfer of an Allogeneic Major Histocompatibility Complex Antigen
Published in Eric Wickstrom, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors, 2020
Alison T. Stopeck, Evan M. Hersh
In a preliminary trial performed at the British Columbia Cancer Agency, patients with melanoma were treated with 6 weekly intratumoral injections of Allovectin-7 regardless of their pre-study HLA-B7 typing (Silver et al., 1996). Three of the seven patients treated tested positive for HLA-B7 by flow cytometry of their peripheral blood mononuclear cells during their initial screening.
Intralesional therapy as a treatment for locoregionally metastatic melanoma
Published in Expert Review of Anticancer Therapy, 2018
John T. Miura, Jonathan S. Zager
Early work assessing Allovectin-7 efficacy reported response rates up to 50% in four different phase I trials [34–37]. In phase II results, VCL-1005–208 was a dose-escalation study that enrolled patients with stage III or IV metastatic melanoma [38]. Patients went on to receive 6 weekly injections ranging from 0.5 to 2 mg of Allovectin-7. A total of 133 patients were enrolled, of which only 127 were evaluated for efficacy. In six patients treated with <2-mg dose, no response was observed. Fifteen patients (11.8%) achieved an overall response rate (ORR: 3% CR, 9% partial response [PR]) with a median duration of response lasting 13.8 months. Additionally, of the patients with stage IV disease, 21% (9/42) demonstrated a response in non-injected lesions. A second phase II study by Gonzalez et al. also reported similar findings. Seventy-seven patients with metastatic melanoma were treated with 10 µg Allovectin-7 weekly for 6 weeks. CR and PR were observed in 3% and 7% of the cohort, respectively, with a median OS of 14 months [39]. Additional phase II trials reported ORR up to 28%, but the overall study cohorts were much smaller in size [32]. Reported side effects among the studies were mild and included paresthesias, myalgias, fatigue, injection site pain, rigors, and flu-like symptoms.