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

Phase 2
18 Years
Open (Enrolling)
Recurrent Neuroendocrine Carcinoma of the Skin, Stage I Neuroendocrine Carcinoma of the Skin, Stage II Neuroendocrine Carcinoma of the Skin, Stage III Neuroendocrine Carcinoma of the Skin, Stage IV Neuroendocrine Carcinoma of the Skin

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Trial Information

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.

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

- 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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

From baseline to 2-4 weeks after the first injection

Safety Issue:


Principal Investigator

Shailender Bhatia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Recurrent Neuroendocrine Carcinoma of the Skin
  • Stage I Neuroendocrine Carcinoma of the Skin
  • Stage II Neuroendocrine Carcinoma of the Skin
  • Stage III Neuroendocrine Carcinoma of the Skin
  • Stage IV Neuroendocrine Carcinoma of the Skin
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
University of California San Francisco Medical Center San Francisco, California  94143