Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088660
Status:
UNKNOWN
Last Update Posted:
2006-02-08
First Post:
2004-07-30
Brief Title:
PANVAC-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen
Sponsor:
Therion Biologics Corporation
Organization:
Therion Biologics Corporation
Study Overview
Official Title:
A Phase III Randomized Controlled Study to Evaluate the Safety and Efficacy of PANVAC-VF in Combination With GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients With Metastatic Stage IV Adenocarcinoma of the Pancreas Who Have Failed a Gemcitabine-Containing Chemotherapy Regimen
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this multi-center randomized controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor GM-CSF versus best supportive care or palliative chemotherapy
Detailed Description:
PANVAC-VF is an investigational cancer vaccine The vaccine is based on the theory that the body 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
All patients will be required to sign an informed consent prior to the performance of any study-related procedures Patients will be screened for eligibility within 14 days prior to their anticipated treatment start date Day 0 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 treatment assignment The ratio of active treatment to control is 11 PANVAC-VF best supportive care or palliative chemotherapy
All patients will be required to sign an informed consent prior to the performance of any study-related procedures Patients will be screened for eligibility within 14 days prior to their anticipated treatment start date Day 0 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 treatment assignment The ratio of active treatment to control is 11 PANVAC-VF best supportive care or palliative chemotherapy
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