Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381173
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2006-09-26
Brief Title:
A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility safety and tolerability of administering ZYC300 with Cyclophosphamide Cytoxan
Detailed Description:
This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies cancerous growths of the ovary breast colon or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy Patients who meet all entry criteria will be administered 600 mgm2 cyclophosphamide intravenously 3 days before each dose of ZYC300 ZYC300 will be administered at 400 micrograms DNAtotal dose every two weeks for a maximum of six doses 6 cycles
ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles This is the first time that ZYC300 and Cyclophosphamide will be given together Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer In this trial the study drug will be used to boost the immune system Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells The T reg cells limit the immune systems attack on infected or abnormal cells In this study the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells
ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles This is the first time that ZYC300 and Cyclophosphamide will be given together Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer In this trial the study drug will be used to boost the immune system Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells The T reg cells limit the immune systems attack on infected or abnormal cells In this study the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells
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