Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121745
Status:
TERMINATED
Last Update Posted:
2007-12-20
First Post:
2005-07-15
Brief Title:
Evaluation of Safety of Rexin-G Gene Transfer for Advanced Pancreatic Cancer
Sponsor:
Epeius Biotechnologies
Organization:
Epeius Biotechnologies
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a dose-seeking study that will test the safety of increasing doses of Rexin-G given intravenously in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy Rexin-G is a tumor-targeted gene therapy vector that contains a killer gene that blocks the action of the human cyclin G1 gene Cyclin G1 is a cell cycle control element that plays an important role in cancer growth When injected into a vein the Rexin-GTM vector seeks out and accumulates in cancerous tumors therefore increasing the concentration of the drug in the cancerous tumors and not in normal neighbouring organs
Detailed Description:
Pancreatic cancer is the fourth leading cause of cancer death in the United States Every year about 30000 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 cells 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 persons 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
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 cells 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 persons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None