Viewing Study NCT00417274



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Study NCT ID: NCT00417274
Status: COMPLETED
Last Update Posted: 2013-04-11
First Post: 2006-12-27

Brief Title: Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
Sponsor: Cleveland BioLabs
Organization: Cleveland BioLabs

Study Overview

Official Title: An Open-Label Phase II Safety Tolerability Drug Level and Efficacy Trial of Quinacrine in Patients With Androgen-Independent Metastatic Prostate Cancer
Status: COMPLETED
Status Verified Date: 2012-09
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 determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer
Detailed Description: Despite a modest improvement in survival with available chemotherapy treatments androgen-independent metastatic prostate cancer remains essentially incurable

Several changes in gene function that characterize malignancy have been identified For example the p53 gene in normal tissue lessens the risk of cancer through growth arrest or cell suicidal programs Thus the silenced p53 gene present in cancer tissue contributes to the growth of the cancer In addition when the p53 gene is silenced a cell survival pathway controlled by the NF-kB gene is activated leading increased cell survival

Quinacrine can activate p53 and inhibit NF-kB thus reestablishing cell suicidal programs and decreasing cell survival in cancer tissue Moreover quinacrine is effective against several prostate tumor cell lines in vitro and has anti-tumor effects against prostate cancer xenografts in mice

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