Trial of pIL-12 Electroporation Malignant Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/14/2016
Start Date:December 2011

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A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma

This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12
DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12
EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor
to initiate and/or enhance anti-tumor immunity.

Plasmid IL-12 (pIL-12) at a concentration of 0.5 mg/mL will be injected intratumorally at a
dose volume of ¼ of the calculated lesion volume and a dose volume per lesion of 0.1 mL for
lesions of volume < 0.4 cm3. Six pulses at field strengths of (E+) of 1500 V/cm and pulse
width of 100 μs at 1-second intervals will be administered using the OMS to each previously
injected tumor.

Two treatment regimens will be explored:

Regimen A: Treatment on Days 1, 8 and 15 every 6 weeks Regimen B: Treatment on Days 1, 5 and
8 every 6 weeks. Lesions will be treated on either Regimen A or Regimen B. Subsequent cycles
may be given at 6-week intervals, for up to 9 treatment cycles in total.

Inclusion Criteria:

- Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma

- Age ≥ 18 years of age

- ECOG performance status 0-2

- Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon,
ipilimumab, or IL-2) with progression or persistent disease

- Patients may have had radiation therapy, but must have progressive disease after
radiation therapy if the lesions to be treated are within the radiation field

- Female patient of childbearing potential has a negative pregnancy test within 14 days
prior to the start of study drug

- Adequate organ function

- Able to give informed consent

Exclusion Criteria:

- Prior therapy with IL-12 or prior gene therapy

- Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of subject
participation on study

- Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess,
etc.) at time of study enrollment

- Pregnant or breast-feeding women

- Patients with electronic pacemakers or defibrillators are excluded from this study

- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has
another confirmed or suspected immunosuppressive or immunodeficient condition
(patients with thyroiditis are eligible)

- Life expectancy of less than 6 months

- History of significant cardiovascular disease (i.e. NYHA class 3 congestive heart
failure; myocardial infarction with the past 6 months; unstable angina; coronary
angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac
arrhythmias)

- Other clinically significant co-morbidities such as uncontrolled pulmonary disease,
uncontrolled diabetes, active CNS disease, active infection or any other condition
that could compromise the patients participation in the study according to the
investigator
We found this trial at
6
sites
Denver, Colorado 80291
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Denver, CO
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3525
Lakeland, Florida 33805
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Lakeland, FL
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Santa Monica, CA
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Bethlehem, Pennsylvania
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Bethlehem, PA
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San Francisco, California 94143
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San Francisco, CA
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Seattle, WA
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