A Phase II Study of Intratumoral Injection of Interleukin-12 Plasmid and in Vivo Electroporation in Patients With Merkel Cell Carcinoma
I. To measure the effect of intratumoral injection of IL-12 plasmid (pIL-12) (interleukin-12
gene) followed by in vivo electroporation (EP) (electroporation-mediated plasmid DNA vaccine
therapy) on the local expression of interleukin-12 (IL-12) in the tumor microenvironment in
patients with Merkel cell carcinoma (MCC).
I. To assess the safety of intratumoral pIL-12 injection and in vivo EP in MCC. II. To
assess the clinical efficacy of this treatment approach in MCC. III. To assess the
immunologic changes resulting from this treatment approach.
Patients receive interleukin-12 gene intratumorally (IT) and undergo electrical discharge
around the tumor site for electroporation-mediated plasmid DNA vaccine therapy on days 1, 5,
and 8. Patients with unresectable disease may receive a second course of treatment in week
7. Patients with localized disease proceed to definitive treatment as determined by the
treating physician starting 2-4 weeks after the first injection.
After completion of study treatment, patients are followed up at weeks 4-8 (for patients who
received definitive treatment) or 12 (for patients with unresectable disease) and then
annually for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who experience at least 2-fold increase in expression of IL-12 protein in the tumor tissue after IT pIL-12 injections and in vivo electroporation
Patients who experience at least 2-fold increase in the expression of IL-12 protein will be counted as having a successful outcome. Patients who do not experience a 2-fold or greater increase in IL-12 protein levels in the injected tumor tissue will be classified as a failure for analysis purpose. The proportion of successful outcomes in this population will be reported with 90% Wilson (score) binomial confidence interval.
From baseline to 2-4 weeks after the first injection
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of California San Francisco Medical Center||San Francisco, California 94143|