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Completed

NCT Number: NCT00223899

A 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.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Location #2, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VCL-IM01 (encoding IL-2) with Electroporation

Genetic

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).

Primary outcomes

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

    Time frame: 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.

    Time frame: After all subjects have been enrolled

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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