Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT02548169
Status:
TERMINATED
Last Update Posted:
2019-01-29
First Post:
2015-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped because of loss of funding and no safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PancVax
Brief Summary:
The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer.
The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
Detailed Description:
This is a single center, exploratory pilot safety, open label, phase I trial that will evaluate the combination of DC vaccination in 2 groups of patients when combined with chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients in each group. Subjects will be assigned to group 1 or group 2 according to the subject's disease stage.
The protocol will be conducted in two stages:
The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with standard chemotherapy. A safety analysis will be performed after the first 3 patients have completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients then the study will proceed with stage 2. Stage 2 will include the enrollment of the remaining 17 patients.
The protocol will be conducted in two stages:
The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with standard chemotherapy. A safety analysis will be performed after the first 3 patients have completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients then the study will proceed with stage 2. Stage 2 will include the enrollment of the remaining 17 patients.
Study Oversight
Has Oversight DMC:
True
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?: