Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137865
Status:
TERMINATED
Last Update Posted:
2013-02-28
First Post:
2005-08-26
Brief Title:
Safety Study of phIL-12-005PPC to Treat Recurrent Ovarian Cancer
Sponsor:
EGEN Inc
Organization:
EGEN Inc
Study Overview
Official Title:
A Phase 1 Open Label Dose Escalation Study of the Safety Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ovarian cancer may be caused by a build-up of genetic defects or damaged genes within the cells of the body Because the genes are damaged the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections The investigational gene transfer agent EGEN-001 phIL-12-005PPC contains the human gene for interleukin-12 IL-12 a cytokine in a special carrier system designed to enter the cells and help the body produce cytokines
This study has two purposes the first is to determine what different strengths of EGEN-001 can be given safely without major side effects and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer
This study has two purposes the first is to determine what different strengths of EGEN-001 can be given safely without major side effects and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer
Detailed Description:
EGEN-001-101 is a Phase 1 open label non-randomized dose escalation study in up to 18 eighteen patients three to six patients in each of the first three cohorts and up to nine patients in a fourth cohort or MTD The fourth cohort or MTD if earlier will be expanded in increments of three patients until a total of 18 patients have been enrolled
Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study Screening evaluations will be performed within 21 days prior to scheduled study drug administration If all eligibility criteria are met the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing Day -7 to allow adequate time for healing around the catheter insertion site Baseline evaluations will be performed prior to dosing At that time the investigator will ensure that the patient remains eligible for participation
All study drug will be administered on an inpatient basis and the patient will remain confined for 24 hours following study drug administration for evaluation of safety and collection of specified body fluid samples for plasmid IL-12-DNA and cytokine determinations Each patient will receive the same dose of EGEN-001 once weekly for four weeks administered on Day 0 Day 7 Day 14 and Day 21 Patients will undergo safety evaluations 1 4 and 24 hours and 3 days following each dose Patients will return to the clinic for safety evaluations three days one week and five weeks one week following the last dose
Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study Screening evaluations will be performed within 21 days prior to scheduled study drug administration If all eligibility criteria are met the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing Day -7 to allow adequate time for healing around the catheter insertion site Baseline evaluations will be performed prior to dosing At that time the investigator will ensure that the patient remains eligible for participation
All study drug will be administered on an inpatient basis and the patient will remain confined for 24 hours following study drug administration for evaluation of safety and collection of specified body fluid samples for plasmid IL-12-DNA and cytokine determinations Each patient will receive the same dose of EGEN-001 once weekly for four weeks administered on Day 0 Day 7 Day 14 and Day 21 Patients will undergo safety evaluations 1 4 and 24 hours and 3 days following each dose Patients will return to the clinic for safety evaluations three days one week and five weeks one week following the last dose
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