Phase I/II Study of Intraperitoneal Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Peritoneal Carcinomatosis
Peritoneal carcinomatosis includes a variety of tumors with extensive metastasis throughout
the peritoneal cavity (inside surface of the abdomen) and can be found with gall bladder,
liver, colon, appendix, ovarian, pancreas, mesothelioma, pseudomyxoma peritonei, rectal,
small bowel and stomach cancers. It broadly includes multiple tumors that develop in and
line the peritoneal abdominal cavity and linings. These tumors may be difficult to
completely remove surgically and may recur despite conventional systemic chemotherapy,
thereby resulting in poor patient outcomes. In preclinical studies, GL-ONC1, an oncolytic
vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor
cells in more than 30 different human tumors. A Phase I clinical study focusing on the
safety and tolerability of GL-ONC1 intravenously administered to patients with a variety of
solid tumor entities has shown that GL-ONC1 is well-tolerated at therapeutic dose levels,
with documented evidence of antitumor activity. This additional Phase I/II study seeks to
evaluate GL-ONC1 administered repetitively every 4 weeks up to 4 cycles via infusion using
an implanted catheter in the peritoneal cavity. In Phase I, patients will be individually
assessed for safety and dose limiting toxicity. The study aims of Phase II portion are
continued collection of safety information to better define the tolerability of GL-ONC1, as
well as viral replication and the action or effect of GL-ONC1 in humans at the selected dose
level and dosing schedule for future trials. Throughout both phases of the study, anti-tumor
effects will be evaluated.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine safety of administering GL-ONC1 intraperitoneally by the evaluation of the number of patients experiencing Adverse Events (type, frequency, and severity)
The safety of GL-ONC1 will be assessed by the evaluation of the type, frequency, and severity of adverse events (AEs), changes in laboratory tests (haematological, chemistry, urinary), immunogenicity and physical examination
Change from baseline over 24 hours, on days 2, 3, 4,5,6, 7 post treatment (Cycle 1) and change from baseline for Cycles 2- 4 CX/Days 1, 2, 3, 5, 8 post-treatment. Each cycle is 4 weeks and treatment will occur for a total of 4 cycles.
Yes
Ulrich M. Lauer, Prof. Dr. med.
Principal Investigator
University Hospital Tuebingen
Germany: Paul-Ehrlich-Institut
Genelux - PO2
NCT01443260
February 2012
November 2013
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