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Status:

COMPLETED

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

Lead Sponsor:

Vical

Conditions:

Metastatic Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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) followe...

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 trea...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2008

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT00223899

    Start Date

    July 1 2005

    End Date

    October 1 2008

    Last Update

    February 27 2019

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    Location #2

    Mobile, Alabama, United States, 36606

    2

    Location #3

    Denver, Colorado, United States, 80045

    3

    Location #1

    Chicago, Illinois, United States, 60068

    4

    Location #4

    Montclair, New Jersey, United States, 07042