- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2010-04-20
2024-07-17
2025-07
71
NCT01088789
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
INTERVENTIONAL
A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine
The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, tail or the uncinate process of the pancreas.
Primary Objective: 1. To evaluate the safety and feasibility of long term boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene given alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, or uncinate process of the pancreas. Secondary Objective: 1. To assess the effect of boost vaccinations and long-term treatment of immune modulating doses of cyclophosphamide on the number, repertoire and avidity of peripheral mesothelin-specific CD8+ T cells. 2. To estimate disease-free and overall survival of surgically resected pancreatic adenocarcinoma patients treated with vaccine boosts with or without low dose cyclophosphamide.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-03-01 | N/A | 2024-09-12 |
2010-03-16 | N/A | 2024-09-19 |
2010-03-17 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Cohort 1 Arm A: Vaccine only. Arm B receives vaccine as well as a single dose of intravenous cyclophosphamide. Arm C: In addition to Vaccine Cohort 3 receives a daily dose of metronomic cyclophosphamide orally. Only patients from the J0810 study are eligible. Cl | BIOLOGICAL: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
|
| OTHER: Cohort 2 Cohort 2 receives vaccine as well as a single dose of intravenous cyclophosphamide. Vaccine-naïve cohort. Closed to enrollment. | BIOLOGICAL: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
|
| OTHER: Cohort 3 Cohort 3 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1568 study are eligible. | BIOLOGICAL: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
|
| OTHER: Cohort 4 Cohort 4 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J15237 study are eligible. | BIOLOGICAL: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
|
| OTHER: Cohort 5 Cohort 5 receives vaccine as well as a single dose of intravenous cyclophosphamide. Only participants from J1766 study are eligible. | BIOLOGICAL: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease free overall survival. | Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0 | total of 13 years with 6 months between vaccines. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
