Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00637390
Status:
TERMINATED
Last Update Posted:
2016-12-02
First Post:
2008-03-10
Brief Title:
A Phase I Study of Alemtuzumab in Patients With Relapsed OvarianPrimary Peritoneal Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Phase I Study of Alemtuzumab in Patients With Relapsed OvarianPrimary Peritoneal Cancer
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Genzyme will no longer supply the study drug for this trial as it does not believe the study will not fully enroll within an appropriate time frame
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ovarian cancer cannot grow without recruiting new blood vessels Studies in humans have identified a novel cell population termed vascular leukocytes VLCs While VLCs are not cancer cells they support the growth of ovarian cancer cells by stimulating the growth of new blood vessels which provide the cancer with nutrients VLCs make a protein termed CD52 An antibody therapeutic Alemtuzumab also know as Campath that kills cells that make the CD52 protein has been successfully used to treat certain lymphomas a type of blood cell cancer that make CD52 protein The purpose of this study is to determine if Alemtuzumab given subcutaneously under the skincan be safely given to patients with ovarian fallopian or primary peritoneal cancers to kill VLCs and determine if Alemtuzumab by eliminating VLCs can restrict tumor growth or increase response rates to chemotherapy given after the discontinuation of chemotherapy
Detailed Description:
None
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