Targeted Delivery of OncoVEX GM-CSF by Endoscopic Ultrasound (EUS)-Guided Fine Needle Injection (FNI) in Patients With Irresectable Pancreatic Cancer: A Pilot Multinational Experiment on Safety and Proof of Concept
The outcome for most patients with pancreatic cancer is very poor. Surgery offers the only
change for cure. Unfortunately, at the time of diagnosis, 80 to 90% of patients have
inoperable or metastatic disease. Chemotherapy (Gemcitabine) and chemoradiation therapy
offer only a small therapeutic effect and primarily affect pain and overall condition. Given
the poor prognosis of pancreatic cancer, many alternative strategies have been tested to
improve treatment results. A wide variety of gene and immunotherapies have been tested.
OncoVEX GM-CSF is a conditionally replication competent herpes simplex type-1 virus designed
for use in solid tumors. It has been specifically modified to replicate in tumors and to
provide a local source of the immune-stimulating cytokine, GM-CSF. It injected directly
into cancer tumors and is believed to destroy tumor cells by direct infection of the tumor
cells and an enhanced immune response due to the release of tumor antigens and GM-CSF
expression.
OncoVEX GM-CSF will be delivered directly to pancreatic tumors using EUS-FNI. A series of
three injections will be administered of 6 weeks. Patients will be hospitalized for the
first injection. Screening will occur within 3 weeks of the first injection and visits for
injections will occur at 0, 3 and 6 weeks. Spiral CT scans of chest and abdomen will be
done prior to each injection and again at 12 weeks (6 weeks after last injection)and also at
18 weeks if response has occurred. Assessments of pain, vital signs and laboratory
evaluations will occur at each visit. If appropriate patients may be offered up to three
additional injections.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse event summaries of events, changes in vital signs, blood chemistry and hematology captured prior to and following treatment to end of study
18 weeks
No
Neil N Senzer, MD
Principal Investigator
Mary Crowley Medical Research Center
United States: Food and Drug Administration
OncoVEX GM-CSF 005/04
NCT00402025
November 2006
March 2010
Name | Location |
---|---|
California Pacific Medical Center | San Francisco, California 94115 |
UCI Medical Center | Irvine, California 92868 |
Mary Crowely Medical Research Center | Dallas, Texas 75246 |