Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to examine the safety of the study drug in patients with locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for this disease. Dendritic cells are cells that are present in the body's immune system that help your body fight disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dendritic cell and Poly-ICLC vaccination | Experimental | Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-ICLC | Biological |
| ||
| dendritic cell |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Number of Participants With Adverse Events (AEs) Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. | from study consent to last treatment (Day 56) |
| Primary Objective | Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients | from study consent to last treatment (Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | Number of Participants With Tumor Response | Average three months Per Participant |
| Secondary Objective | Measure overall Survival |
Not provided
Inclusion Criteria:
Each of the following criteria must be met in order for a patient to be considered eligible for enrollment.
Exclusion Criteria:
Each of the following criteria should not be present in order for the patient to be considered eligible for enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Not provided
| ID | Term |
|---|---|
| C019531 | poly ICLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
|
| Post treatment |