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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 15, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: Plasmid INTERLEUKIN-12
Device: Intratumoral Electroporation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by OncoSec Medical Incorporated:

Primary Outcome Measures:
  • Best overall objective response rate by modified "skin" RECIST [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 51
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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

Detailed Description:

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.

  Eligibility

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

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
  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: NCT01502293

Contacts
Contact: Mai H Le, M.D. 858-255-4729 investors@oncosec.com

Locations
United States, California
UCSF Helen Diller Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Lawrence Chen       Lawrence.Chen@ucsf.edu   
Sub-Investigator: Adil Daud, MD         
Principal Investigator: Alain Algazi, MD         
John Wayne Cancer Institute Completed
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Denver Not yet recruiting
Denver, Colorado, United States, 80045
Contact: Grant Chambers, MPH    720-848-7135    grant.chambers@ucdenver.edu   
Principal Investigator: Karl Lewis, MD         
United States, Florida
Lakeland Regional Cancer Center Completed
Lakeland, Florida, United States, 33805
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Robyn Rex, RN,OCN,CCRP    484-503-4152    robyn.rex@sluhn.org   
Principal Investigator: Sanjiv S Agarwala, MD         
United States, Washington
Seattle Cancer Care Alliance /University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Nichole Real    206-288-7476    nreal@seattlecca.org   
Principal Investigator: Shailender Bhatia, MD         
Sponsors and Collaborators
OncoSec Medical Incorporated
Investigators
Study Director: Mai H Le, M.D. OncoSec Medical Incorporated
  More Information

No publications provided

Responsible Party: OncoSec Medical Incorporated
ClinicalTrials.gov Identifier: NCT01502293     History of Changes
Other Study ID Numbers: OMS-I100, 11854
Study First Received: December 21, 2011
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 30, 2015