Trial of pIL-12 Electroporation Malignant Melanoma (IL12MEL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by OncoSec Medical Incorporated
Sponsor:
Information provided by (Responsible Party):
OncoSec Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01502293
First received: December 21, 2011
Last updated: March 23, 2015
Last verified: March 2015

December 21, 2011
March 23, 2015
December 2011
December 2015   (final data collection date for primary outcome measure)
Best overall objective response rate by modified "skin" RECIST [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Distant response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Median overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Objective response rate by irRC [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of objective response (DOR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Time to first objective response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Median progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Regression rate of treated and untreated lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Comparison of efficacy endpoints between the two treatment regimens [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Comparison of number of participants with AEs between the two treatment regimens [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Comparison of pain scores between the two treatment regimens as measured by VAS for pain. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Local response rate and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The local response rate, progression free survival and overall survival of IL-12 plasmid electroporation.
  • Safety and adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The safety of IL-12 plasmid electroporation as assessed by adverse events.
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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, with dosing on days 1, 8 and 15, every 6 weeks until disease progression or unacceptable toxicity for up to 1 year.
    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.
 
Recruiting
51
Not Provided
December 2015   (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
Both
18 Years and older
No
Contact: Mai H Le, M.D. 858-255-4729 investors@oncosec.com
United States
 
NCT01502293
OMS-I100, 11854
Yes
OncoSec Medical Incorporated
OncoSec Medical Incorporated
Not Provided
Study Director: Mai H Le, M.D. OncoSec Medical Incorporated
OncoSec Medical Incorporated
March 2015

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