Viewing Study NCT00043212



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00043212
Status: WITHDRAWN
Last Update Posted: 2013-05-01
First Post: 2002-08-06

Brief Title: Study of a Drug DCVax tm-Prostate to Treat Prostate Cancer When Hormone Therapy is no Longer Effective
Sponsor: Northwest Biotherapeutics
Organization: Northwest Biotherapeutics

Study Overview

Official Title: A Randomized Double-blind Placebo-controlled Phase III Clinical Trial Evaluating DCVaxtm-Prostate Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
Status: WITHDRAWN
Status Verified Date: 2013-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Redirection of company goals
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 clinical research study is to assess the safety and efficacy of an investigational therapy called DCVaxTM-Prostate
Detailed Description: Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions The experimental therapy uses a patients own white blood cells and teaches the cells to recognize a flag on prostate cancer cells This may help the immune system destroy prostate cancer cells Side effects reported from the Phase III trial include skin reactions of redness pain swelling at the injection site and short-lived headache fever fatigue Full details are available in the informed consent

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