Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078585
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2004-03-01
Brief Title:
PROSTVAC-VFTRICOM Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Sponsor:
Bavarian Nordic
Organization:
Bavarian Nordic
Study Overview
Official Title:
A Phase II Randomized Double Blind Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC-VFTRICOM in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2017-09
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:
PROSTVAC-VF is an investigational cancer vaccine The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells These targets are called Tumor Associated Antigens or TAAs This trial will help determine if this vaccine can help fight cancer
This multi-center double-blind randomized empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VFTRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer AIPC
All patients will be required to sign an informed consent prior to the performance of any on-study procedures Patients will be screened for eligibility within 14 days prior to vaccine administration Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment The ratio of active treatment to empty vector control placebo is 21
This multi-center double-blind randomized empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VFTRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer AIPC
All patients will be required to sign an informed consent prior to the performance of any on-study procedures Patients will be screened for eligibility within 14 days prior to vaccine administration Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment The ratio of active treatment to empty vector control placebo is 21
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