NCT00223899

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2005

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

September 13, 2005

Last Update Submit

February 25, 2019

Conditions

Metastatic Melanoma

Keywords

MelanomaElectroporationIL-2

Outcome Measures

Primary Outcomes (1)

  • Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma

    After all subjects have been enrolled

Secondary Outcomes (1)

  • 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.

    After all subjects have been enrolled

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

VCL-IM01 (encoding IL-2) with ElectroporationGENETIC

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).

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Location #2

Mobile, Alabama, 36606, United States

Location

Location #3

Denver, Colorado, 80045, United States

Location

Location #1

Chicago, Illinois, 60068, United States

Location

Location #4

Montclair, New Jersey, 07042, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dmitri D. Kharkevitch, MD, PhD

    Vical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2008

Study Completion

October 1, 2008

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(4)