What question did this study set out to answer?

To evaluate the safety, tolerability, gene expression efficiency, and therapeutic potential of in vivo plasmid interleukin-12 electroporation directly into tumors in patients with metastatic melanoma.

November 24, 2008Journal of Clinical Oncology

Phase I Trial of Interleukin-12 Plasmid Electroporation in Patients With Metastatic Melanoma

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To evaluate the safety, tolerability, gene expression efficiency, and therapeutic potential of in vivo plasmid interleukin-12 electroporation directly into tumors in patients with metastatic melanoma.
Conducted a phase I dose-escalation trial enrolling 24 patients with metastatic melanoma treated across seven dose levels.
Delivered plasmid IL-12 into metastatic lesions followed immediately by electroporation (six 100-µs pulses at 1,300 V/cm using a six-electrode array) on days 1, 5, and 8 of a 39-day cycle.
Assessed pre- and post-treatment biopsies for IL-12 protein levels, histologic changes, and systemic disease response.
Treatment was well tolerated with minimal systemic toxicity; transient local pain was the primary reported adverse effect.
Post-treatment biopsies demonstrated plasmid dose-proportional increases in local IL-12 protein expression alongside pronounced tumor necrosis and lymphocytic infiltration.
Among 19 patients with untreated distant metastases and no concurrent systemic therapy, 2 patients (10%) experienced complete regression of all lesions, and 8 patients (42%) achieved partial response or disease stabilization.

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Implication

Phase I trial demonstrates safe gene delivery and antitumor responses in metastatic melanoma, indicating that in vivo DNA electroporation is an effective immunotherapy modality.

Cite This Study

Daud et al. (2008) studied this question.

synapsesocial.com/papers/6a00d758b124fe5819861676 https://doi.org/10.1200/jco.2007.15.6794

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Implication

Phase I trial demonstrates safe gene delivery and antitumor responses in metastatic melanoma, indicating that in vivo DNA electroporation is an effective immunotherapy modality.

Phase I Trial of Interleukin-12 Plasmid Electroporation in Patients With Metastatic Melanoma

Key Points

Discussion

Implication

Cite This Study

Phase I Trial of Interleukin-12 Plasmid Electroporation in Patients With Metastatic Melanoma

Key Points

Discussion

Implication

Cite This Study