IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer
Condition: Merkel Cell Carcinoma
MeSH terms: Carcinoma, Merkel Cell; Carcinoma
Intervention: Tavokinogene Telseplasmid (tavo); OncoSec Medical System (OMS)
Intervention description: Patients received intratumoral injection(s) of tavo.; Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.
Intervention MeSH terms: Interleukin-12
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the effectiveness of ImmunoPulse IL-12® in treating patients with
      Merkel cell cancer. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene
      (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid
      deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical
      System (OMS). Placing the gene for interleukin-12 into Merkel cells may help the mount an
      effective anti-tumor immune response to kill tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have biopsy-confirmed Merkel cell carcinoma

          -  Patients must have at least one injectable lesion, defined as an easily palpable
             superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be
             accurately localized, stabilized by palpation, and is superficial enough to enable
             intratumoral injection and electroporation; the injectable lesion must not be in close
             proximity to another tissue (e.g. nerve, bone) that could put patient safety at risk

          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2

          -  Life expectancy of greater than three months

          -  Absolute neutrophil count > 1,000/uL

          -  Platelet count > 50,000/uL

          -  Creatinine =< 2.0 x upper limit of normal (ULN)

          -  Bilirubin =< 2.0 x ULN

          -  Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN

          -  Patients must be willing, at the time of the entry to the study, to undergo the
             pre-treatment fine needle aspiration (FNA) plus biopsy (if indicated) AND the
             post-treatment FNA plus biopsy (or surgery) of at least one injected lesion (FNA is
             essential to determine the primary endpoint of the study); NOTE: The pre-treatment
             biopsy will be obtained from a superficial not-to-be-injected lesion; the
             post-treatment biopsy of an injected lesion will be obviated if definitive surgical
             resection is planned

          -  The effects of this treatment approach on the developing human fetus are unknown; for
             this reason, women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation; should a woman become pregnant or
             suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

          -  Both men and women, and members of all races and ethnic groups are eligible for this
             trial

        Exclusion Criteria:

          -  Patients who have had prior chemotherapy, investigational therapy or a major surgical
             procedure within 4 weeks or radiotherapy within 2 weeks prior to first day of
             treatment

          -  Patients must not be receiving concurrently any other anti-cancer treatment (including
             topical agents such as imiquimod) or investigational agents, which could potentially
             interfere with the study treatment and/or study endpoints

          -  Patients with active untreated brain metastases will be excluded

          -  Pregnant or breast feeding women are excluded because effects of this treatment on the
             fetus or passage through milk are unknown

          -  Patients with electronic pacemakers or defibrillators or those with a history of life
             threatening cardiac arrhythmia or uncontrolled seizure disorder are excluded

          -  Use of any immunosuppressive treatments including corticosteroids, cyclosporine,
             mycophenolate mofetil et cetera, within 4 weeks prior to Day 1 of treatment will not
             be allowed; NOTE: Patients on topical or physiologic doses (for hormone-replacement
             therapy) of corticosteroids will be allowed

          -  Patients, who are judged to be immunosuppressed due to uncontrolled human
             immunodeficiency virus (HIV) infection, severe uncontrolled diabetes, concurrent
             hematological malignancy, or other comorbidities, will be excluded

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             serious infection, symptomatic congestive heart failure, unstable angina pectoris,
             serious autoimmune conditions or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Patients receiving concurrent therapeutic-dose anticoagulation will be excluded