Clinical Trial: IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Intratumoral Injection of Interleukin-12 Plasmid and in Vivo Electroporation in Patients With Merkel Cell Carcinoma

Brief Summary: This phase II trial studies how well giving interleukin-12 gene and in vivo electroporation-mediated plasmid DNA vaccine therapy works in treating patients with Merkel cell cancer. Placing the gene for interleukin-12 into Merkel cells may help the body build an effective defense to kill tumor cells

Detailed Summary:

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.


Sponsor: OncoSec Medical Incorporated

Current Primary Outcome: 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 [ Time Frame: From baseline to 2-4 weeks after the first injection ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety of intratumoral pIL-12 injections and in vivo electroporation in patients with MCC as assessed by the adverse events [ Time Frame: At days 1, 5, and 8; during weeks 3-4; and at 4-8 or 12 weeks ]
  • Objective responses in injected and non-injected (distant) lesions [ Time Frame: At 2-4 weeks, week 6, and week 12 ]
  • Time to relapse or time to progression [ Time Frame: At 2-4 weeks, week 6, and week 12 ]
  • Overall survival [ Time Frame: At 4-8 or 12 weeks and then annually for up to 5 years ]
  • Immunologic effects of IT pIL-12 injection and in vivo EP [ Time Frame: At baseline and 2-4 weeks after the first injection ]


Original Secondary Outcome: Same as current

Information By: OncoSec Medical Incorporated

Dates:
Date Received: September 23, 2011
Date Started: November 2011
Date Completion:
Last Updated: February 24, 2017
Last Verified: December 2016