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:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00323206
First received: May 5, 2006
Last updated: January 27, 2009
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 Phase
Malignant Melanoma
Genetic: IL-12pDNA
Procedure: electroporation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:
  • toxicity profile
  • maximum tolerated (MTD) dose
  • recommended dose for Phase II study
  • local and systemic response
  • local and systemic expression of IL-12 and IFN gamma

Estimated 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 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/mm3 and platelet count > 100,000 /mm3 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00323206     History of Changes
Other Study ID Numbers: MCC-13224
Study First Received: May 5, 2006
Last Updated: January 27, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 16, 2014