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Introduction to Clinical Trials

Introduction to Clinical Trials

Review frequently asked questions and introductory information about clinical trials.

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List of Clinical Trials

Open Clinical Trial

Phae I trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients with Metastatic Colorectal Cancer to the Liver

This is a research study of gene therapy to treat metastatic colorectal cancer. A metastatic colorectal tumor in the liver is injected with a genetically altered virus. This altered virus (related to the "common cold" virus) cannot reproduce itself but can produce a substance called interleukin-12 (IL12). IL12 can enhance the ability of the body's immune system to destroy tumor cells. The injection of the altered virus is performed by placing one to three needles through the skin into the tumor in the liver. No surgery is required for the injection, which is performed under local anesthesia and with the assistance of an ultrasound examination to track the needles placed into the tumor. Blood tests and radiology scans will be performed before and after the virus injection to check for side effects and for decrease in the size of the tumors in the body. The virus injection has not been approved by the United States Food and Drug Administration (FDA) for commercial use in the treatment of metastatic colorectal cancer. Animal studies have shown that a single injection of the altered virus into a tumor in the liver can produce a strong immune response which led to the destruction of tumors in other organs as well and to some of the treated animals living longer.

  • Phase

    I

  • Compensation

    N

  • Inclusion

    Men or women with metastatic colorectal cancer: - At least one metastatic tumor must be in the liver and measures at least 2 cm in diameter. - Patients may have additional metastatic tumors in or outside the liver. - Patients may have had prior treatment for colorectal cancer.

  • Exclusion

    More than 40% of the liver involved with tumor. Severe liver diseases wih poor liver function. No active infection, including HIV.

  • Research Study Site

    Mount Sinai Medical Center

  • Department Name

    MSSM Medicine

  • Contact Information

    Deborah Lehrer [Coordinator]
    R.N.
    deborah.lehrer@mssm.edu
    212-824-7308 8-7308

  • GCO Number

    97-564

  • IRB Start/End Date

    June 1, 2009 to May 31, 2010

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