Header Images
 
 
 
 

ITOR Biosafety Level ll Program Gene Transfer Therapy Trials

The Institute for Translational Oncology Research (ITOR) of Greenville Health System (GHS) is committed to gene transfer therapies and technologies. Gene therapy is a technique for correcting defective genes responsible for disease development.

Researchers may use one of several approaches for correcting faulty genes:

  • A normal gene may be inserted into a nonspecific location within the genome to replace a nonfunctional gene. This approach is most common.
  • An abnormal gene could be swapped for a normal gene through homologous recombination.
  • The abnormal gene could be repaired through selective reverse mutation, which returns the gene to its normal function.
  • The regulation (the degree to which a gene is turned on or off) of a particular gene could be altered.

Gene transfer materials/technologies that are subject to the National Institutes of Heath Guidelines for Research Involving Recombinant DNA Molecules must undergo review and approval by an institutional biosafety committee. Recombinant DNA molecules are defined as molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell.

As a major research institution, ITOR of GHS provides assurance that its sponsored research activities are in compliance with federal, state, and local regulations and guidelines. The Western Institutional Biosafety Committee (WIBC) is the reviewing body for ITOR's research and provides authorization for the Institute to conduct that research.

The ITOR Clinical Research Unit (CRU) Actively Conducts Gene Transfer Therapy. Trials that are open and closed to enrollment are listed below:

ITOR Gene Transfer Therapy Trials Open to Enrollment:

  • Lucanix as Maintenance Therapy for Stage III/IV NSCLC with Stable Disease or Response Following Front-Line Platinum Based Therapy:
    Lucanix is an allogeneic vaccine cocktail modified with a TGF-β2 antisense vector.
  • OncoVEX for Metastatic Melanoma:
    OncoVEX is a herpes simplex virus with GM-CSF given as an intratumoral injection.

ITOR Gene Transfer Therapy Trials Closed to Enrollment:

  • TNFerade Plus Radiation in Patients with Advanced Melanoma:
    TNFerade is a non-replicating adenovirus ligated upstream from human TNF transgene allowing maximum gene expression in presence of ionizing radiation and is given as an intratumoral injection into subcutaneous lesions.
  • TNFerade Biologic with 5FU and XRT as First Line Therapy for Locally Advanced, Unresectable Pancreatic Cancer:
    TNF transgene allowing maximum gene expression in presence of ionizing radiation and is given as a CT guided intratumoral injection.
  • Intravesical CG0070 with *DDM washing for Transitional Cell Carcinoma of the Bladder:
    CG0070 is a conditionally replicating oncolytic adenovirus regulated by a promoter upregulated in Rb pathway defective tumor cells. It selectively expresses GM-CSF
  • GI4000/Placebo + Gemcitabine for Completely Resected Pancreatic Cancer:
    GI4000 is a recombinant heat inactivated yeast engineered to express one of three mutated Ras oncoproteins
  • Taxotere plus GVAX versus Taxotere/Prednisone for Hormone Refractory Chemo Na´ve Metastatic Prostate Cancer:
    CG1940 and CG8711 are components of a prostate adenocarcinoma cell line genetically modified to secrete GM-CSF into tumor cells ex vivo using a recombinant adeno-associated viral vector.
  • Seneca Valley Virus (SVV-001) for Neuroendocrine Solid Tumors:
    SVV-001 is a replication competent picornavirus
  • JX594 for Metastatic Melanoma:
    JX594 is a replication-competent, GM-CSF transgene-expressing therapeutic vaccinia virus given as an intratumoral injection.
  • JX594 for Advanced Solid Tumors:
    JX594 is a replication-competent, GM-CSF transgene-expressing therapeutic vaccinia virus given intravenously.