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

Melanoma Research
|November 23, 2006
PubMed

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.