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Trial of pIL-12 Electroporation Malignant Melanoma (IL-12MEL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OncoSec Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01502293
First received: December 21, 2011
Last updated: February 24, 2017
Last verified: December 2016
December 21, 2011
February 24, 2017
December 2011
December 2016   (Final data collection date for primary outcome measure)
Best overall objective response rate by modified "skin" RECIST [ Time Frame: 1 year ]
Distant response rate [ Time Frame: 1 year ]
The distant response rate of patients treated with IL-12 plasmid electroporated in vivo into cutaneous melanoma lesions.
Complete list of historical versions of study NCT01502293 on ClinicalTrials.gov Archive Site
  • Safety of pIL-12 EP by assessment of AEs using NCI CTCAE v4.0 [ Time Frame: 1 year ]
  • Median overall survival (OS) [ Time Frame: 5 years ]
  • Objective response rate by irRC [ Time Frame: 5 years ]
  • Duration of objective response (DOR) [ Time Frame: 5 years ]
  • Time to first objective response [ Time Frame: 1 year ]
  • Median progression free survival [ Time Frame: 5 years ]
  • Regression rate of treated and untreated lesions [ Time Frame: 1 year ]
  • Comparison of efficacy endpoints between the two treatment regimens [ Time Frame: 5 years ]
  • Comparison of number of participants with AEs between the two treatment regimens [ Time Frame: 5 years ]
  • Comparison of pain scores between the two treatment regimens as measured by VAS for pain. [ Time Frame: 1 year ]
  • Local response rate and overall survival [ Time Frame: 2 years ]
    The local response rate, progression free survival and overall survival of IL-12 plasmid electroporation.
  • Safety and adverse events [ Time Frame: 2 years ]
    The safety of IL-12 plasmid electroporation as assessed by adverse events.
  • Duration of response [ Time Frame: 2 years ]
    The duration of response and time to objective response.
Not Provided
Not Provided
 
Trial of pIL-12 Electroporation Malignant Melanoma
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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Melanoma
  • Biological: Plasmid INTERLEUKIN-12
    Patients will receive intratumoral injection(s) of pIL-12.
    Other Name: pIL-12
  • Device: Intratumoral Electroporation
    Immediately following intratumoral injection of pIL-12, electroporation will follow by electrical discharge around the tumor site using the OMS system.
    Other Name: EP
  • Experimental: Main Study
    Plasmid interleukin-12 followed by intratumoral electroporation (pIL-12 EP). Treatment cycles consisting of 3 treatments over 1 week period, repeated at 3-month intervals until disease progression or unacceptable toxicity for up to 1 year.
    Interventions:
    • Biological: Plasmid INTERLEUKIN-12
    • Device: Intratumoral Electroporation
  • Experimental: Addendum Study
    Plasmid interleukin-12 followed by intratumoral electroporation (pIL-12 EP). Treatment cycles occur every 6 weeks and two treatment regimens will be explored: Regimen A [treatment on days 1, 8 and 15] -or- Regimen B [treatment on days 1, 5, and 8] and repeated up to 9 treatment cycles (1 year) until disease progression or unacceptable toxicity.
    Interventions:
    • Biological: Plasmid INTERLEUKIN-12
    • Device: Intratumoral Electroporation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
February 2017
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01502293
OMS-I100
11854 ( Other Identifier: University of California, San Francisco )
Yes
Not Provided
Not Provided
OncoSec Medical Incorporated
OncoSec Medical Incorporated
Not Provided
Not Provided
OncoSec Medical Incorporated
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP