Phase I Evaluation of Safety of Intravenous Infusion of a Pathotropic Vector Bearing a Cytocidal Cyclin G1 Construct (Rexin-G) as Intervention for Locally Advanced and Metastatic Pancreatic Cancer Refractory to Standard Chemotherapy
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Every
year, about 30,000 new patients are diagnosed with pancreatic cancer, and most will die
within the year. The few patients that live beyond one year are those who have operable
tumors whose cancer has not spread beyond the pancreas. There is no effective treatment for
pancreatic cancer that impacts survival beyond a few more months. Therefore, innovative
treatments are urgently needed. A number of experimental therapies are currently under
investigation, and gene therapy is a viable therapeutic option.
A gene called cyclin G1 has been shown to play a very important part in cancer growth. In
animal experiments, when this cyclin G1 gene is blocked, the cancer cells grow much slower
or even die. This study will test the drug, Rexin-G, which contains a gene that works by
getting rid of the cyclin G1 gene. The new gene will get into the tumor cells using a
"vehicle" to carry it into the cells. The "vehicle" that will be used is a virus that has
been changed so that it is not likely to cause disease. This "vehicle" is called a vector.
When injected into a vein, the Rexin-G vector is designed to seek out and accumulate in
cancerous tumors, therefore, increasing the concentration of the drug in the area of the
cancer and not in normal neighbouring organs. When the killer gene gets into the cancer
cell, it becomes part of the cell's genes and tells the cancer cell to begin using the new
gene instead of the cyclin G1 gene. It is hoped that the Rexin-G will arrest the growth of
the cancer or eradicate the tumor.
The goals of the study are to determine how much Rexin-G can be given to a patient, to
assess how long Rexin-G stays in the body when injected into a vein, and if the drug would
cause antibodies to form, transfer the gene to normal tissues or pass on the gene to another
person or the person's offspring. The final goal is to determine if the Rexin-G vector can
shrink the tumor by comparing the size of the tumor nodules measured by CT scan or MRI
before and after the Rexin-G treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the dose limiting toxicity and maximum tolerated dose of Rexin-G administered as intravenous infusions; To evaluate pharmacokinetics of Rexin-G
Evanthia Galanis, M.D.
Mayo Clinic Rochester Minnesota
United States: Food and Drug Administration
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