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Published on: July 31, 2016
Phase 2 trial of Allovectin-7 in advanced metastatic melanoma
Rene Gonzalez1, Laura Hutchins, John Nemunaitis
1University of Colorado Cancer Center, Aurora, CO 80010-5010, USA. rene.gonzalez@uchsc.edu
Abstract:
Treatment of metastatic melanoma with chemotherapeutic regimens has led to disappointing response rates, duration of response and no appreciable impact on survival. Intralesional injection of a low dose of an HLA-B7/beta2 microglobulin plasmid formulated with cationic lipids (Allovectin-7 is a registered trademark of Vical, Incorporated, San Diego, California, USA) has been shown previously to be safe and well tolerated. A phase 2, open-label study was performed at 16 centers in the United States. Seventy-seven patients were treated with 10 mug intralesional Allovectin-7 weekly for 6 weeks and clinical response to treatment were evaluated by World Health Organization criteria. Minimal adverse events were associated with the Allovectin-7 injections. Seven patients (9.1%) had complete or partial response with 4.8 months median duration of response. Allovectin-7 was shown to be safe and exhibit biological activity at this dose. Its safety profile may enable Allovectin-7 to be used at higher doses, which may provide greater clinical activity.
Insights
Intralesional Allovectin-7 showed minimal adverse events in metastatic melanoma patients. This investigational therapy demonstrated biological activity and a favorable safety profile for potential dose escalation.
Area of Science:
- Oncology
- Immunotherapy
- Gene Therapy
Background:
- Metastatic melanoma treatment with chemotherapy yields poor outcomes.
- Intralesional Allovectin-7, an HLA-B7/beta2 microglobulin plasmid, is a potential melanoma therapeutic.
- Previous studies indicated Allovectin-7 is safe and well-tolerated.
Purpose of the Study:
- To evaluate the safety and clinical activity of intralesional Allovectin-7 in patients with metastatic melanoma.
- To determine response rates and duration of response for Allovectin-7 therapy.
Main Methods:
- A phase 2, open-label, multi-center study.
- Seventy-seven patients received 10 µg intralesional Allovectin-7 weekly for six weeks.
- Clinical responses were assessed using World Health Organization criteria.
Main Results:
- Allovectin-7 treatment was associated with minimal adverse events.
- Seven patients (9.1%) achieved a complete or partial response.
- The median duration of response was 4.8 months.
Conclusions:
- Intralesional Allovectin-7 is safe and well-tolerated in metastatic melanoma patients.
- The therapy demonstrated biological activity at the tested dose.
- The favorable safety profile supports further investigation at higher doses for enhanced clinical activity.
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