A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

February 25, 2019 updated by: Vical

A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma

To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).

Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.

Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • Location #2
    • Colorado
      • Denver, Colorado, United States, 80045
        • Location #3
    • Illinois
      • Chicago, Illinois, United States, 60068
        • Location #1
    • New Jersey
      • Montclair, New Jersey, United States, 07042
        • Location #4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria - Key criteria include:

  • Confirmed recurrent metastatic melanoma
  • Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
  • Able to carry out normal daily activities and light work without assistance
  • Not currently receiving chemotherapy or immunotherapy
  • Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
  • Able and willing to give informed consent.

Exclusion Criteria - Key criteria include:

  • History of brain tumors (resected or stereotactically treated is allowed)
  • History of liver tumors
  • Subjects whose melanoma can be cured by surgery
  • Pregnant
  • Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).
Genetic: VCL-IM01 (encoding IL-2) with Electroporation
IL-2-encoding plasmid formulated in phosphate-buffered saline at 0.5 mg/mL, 1.5 mg/mL, and 5.0 mg/mL (VCL-IM01) intratumorally injected and followed by electroporation with Inovio MedPulser® 1.0 cm array with needles up to 3 cm long (one 6-pulse cycle per tumor).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
Time Frame: After all subjects have been enrolled
After all subjects have been enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2.
Time Frame: After all subjects have been enrolled
After all subjects have been enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vical

Investigators

  • Study Director: Dmitri D. Kharkevitch, MD, PhD, Vical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM01-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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