Overview

This trial is active, not recruiting.

Condition melanoma
Treatments plasmid interleukin-12, intratumoral electroporation
Phase phase 2
Sponsor OncoSec Medical Incorporated
Start date December 2011
End date June 2016
Trial size 51 participants
Trial identifier NCT01502293, 11854, OMS-I100

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
plasmid interleukin-12 pIL-12
Patients will receive intratumoral injection(s) of pIL-12.
intratumoral electroporation EP
Immediately following intratumoral injection of pIL-12, electroporation will follow by electrical discharge around the tumor site using the OMS system.
(Experimental)
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.
plasmid interleukin-12 pIL-12
Patients will receive intratumoral injection(s) of pIL-12.
intratumoral electroporation EP
Immediately following intratumoral injection of pIL-12, electroporation will follow by electrical discharge around the tumor site using the OMS system.

Primary Outcomes

Measure
Best overall objective response rate by modified "skin" RECIST
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by OncoSec Medical Incorporated.
Location data was received from the National Cancer Institute and was last updated in May 2016.