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Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Gene Vector Laboratory
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00323206
First received: May 5, 2006
Last updated: February 20, 2017
Last verified: January 2009
  Purpose
The purpose of this research study is to study a type of gene therapy treatment called plasmid electroporation. This type of treatment involves the injection of a gene into some melanoma tumors located near the surface of the skin, followed by a burst of electricity into the tumor to cause the tumor to take up the gene. This study is a Phase I study to determine the side effects and the correct dose of this type of treatment and also its effectiveness in treating melanoma. While the electroporation technique has been used in people, the combination of plasmid injection and electroporation is being tried in human beings for the first time.

Condition Intervention
Malignant Melanoma
Biological: IL-12p DNA
Procedure: Intratumoral Electroporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase I Trial of Intratumoral pIL-12 Electroporation in Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 8 weeks ]
    MTD of intralesionally electroporated IL-12 plasmid (pIL-12) as well as a recommended dose for Phase II study. Dose-Limiting Toxicity (DLT): will be defined as hematologic toxicities or diarrhea greater than grade 3, and nonhematologic toxicities greater than grade 2 as defined in the NCI common toxicity criteria, Version 3.0. Significant local skin breakdown, cellulitis, bleeding or ulceration will preclude treatment of particular tumor nodules although treatment of other nodules can continue.


Secondary Outcome Measures:
  • Local and Systemic Response [ Time Frame: 8 weeks ]
    Number of participants with tumor response.


Other Outcome Measures:
  • Local and Systemic Expression of IL-12 and IFN Gamma [ Time Frame: 8 weeks ]
    Cytokine expression measured by enzyme-linked immunosorbent assay (ELISA).


Enrollment: 24
Study Start Date: June 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-tumoral Electroporation of pIL-12
Participants will receive intra-tumoral injection of pIL-12 followed immediately by electrical discharge around the tumor site resulting in electroporation of plasmid DNA into tumor cells. For each lesion selected for therapy, a total of three electroporation treatments will be performed.
Biological: IL-12p DNA
Plasmid IL-12 will be administered as an intratympanic (IT) injection.
Other Names:
  • Plasmid IL-12
  • pIL-12
  • plasmid DNA
Procedure: Intratumoral Electroporation
The electroporation apparatus with the electrical contacts will be placed around the tumor site and activated.
Other Name: plasmid electroporation

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have cytologically/histologically documented metastatic malignant melanoma with lesions near the skin that would be accessible to electroporation and Fine Needle Aspiration (FNA) and biopsy.
  • Age > 18 years old
  • Patients must have ECOG performance status 0-2
  • Patients may have had prior chemotherapy or immunotherapy (with vaccines or Interferon or IL-2) with progression or persistent disease. All chemotherapy or immunotherapy must be stopped for 4 weeks prior to electroporation. Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be electroporated are within the radiation field. In addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated.
  • Patients must be able to give informed consent and able to follow guidelines given in the study
  • Patients must have a minimum of two eligible tumors and may have up to four eligible tumors treated with electroporation.

Exclusion Criteria:

  • Patients may not have had prior therapy with IL-12 or prior genetic therapy
  • Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
  • Patients must have adequate renal and normal hepatic function (creatinine < 1.5 x upper limit of normal (ULN), bilirubin and SGOT (AST) within institutional normal limits) obtained within 4 weeks prior to registration.
  • Patients must have absolute neutrophil count (ANC) > 1500/mm^3 and platelet count > 100,000 /mm^3 within 4 weeks prior to registration.
  • Pregnant and breast feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.
  • Women of childbearing age must have a negative pregnancy test and be willing to use a highly effective method of contraception. Men who are sexually active must also be willing to use an accepted and effective method of contraception.
  • Patients with electronic pacemakers or defibrillators are excluded from this study as the effect of electroporation on these devices is unknown. Patients with significant cardiac arrhythmia's (including ventricular tachycardia, ventricular fibrillation or WPW syndrome) are also excluded.
  • Patients with a history of epilepsy are excluded unless they have been seizure free over the last 5 years and are thought to be at low risk for seizure by their neurologist.
  • Tumors that invade the bone, major blood vessels or nerves are ineligible because those tumors are contraindications to the use of electroporation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323206

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Gene Vector Laboratory
Investigators
Principal Investigator: Adil Daud, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00323206     History of Changes
Other Study ID Numbers: MCC-13224
Study First Received: May 5, 2006
Last Updated: February 20, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
melanoma
electroporation
IL-12
gene therapy
gene transfer

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-12
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 21, 2017