Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
August 6, 2025 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Safety and Feasibility Trial of 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 Surgically Resected Pancreatic Adenocarcinoma
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 (GVAX Pancreas Vaccine) 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 pancreas.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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:
- 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.
- To estimate disease-free and overall survival of surgically resected pancreatic adenocarcinoma patients treated with vaccine boosts with or without low dose cyclophosphamide.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Has a history of surgically resected and pathologically proved AJCC stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas.
- Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766.
- Cohort 2: Have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation.
- Cohorts 1, 3, 4 and 5: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior.
- Has received the last anti-cancer therapy at least 28 days ago.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has provided informed consent.
- Has adequate hematologic function.(Hemoglobin ≥ 9 g/dL ANC ≥ 1500/mm3 Platelets ≥ 100,000 K/ mm3).
- Has adequate renal function (Serum creatinine ≤ 2 mg/dL).
- Has adequate hepatic function. (Bilirubin ≤ 2.0 mg/dl, unless known Gilbert's Syndrome; AST, ALT and amylase ≤ 2x upper limit of normal, Alk Phos ≤ 5x upper limit of normal).
- Agree to use adequate birth control, if of childbearing potential.
Exclusion Criteria:
- Has radiographic evidence of pancreatic cancer recurrence.
- Has any documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis,or vasculitis.
- Has any uncontrolled medical problems.
- Has had systemic steroid therapy within 28 days before vaccine administration.
- Has an anticipated need for systemic steroid therapy within 28 days after vaccine administration.
- Has any evidence of active infections.
- Is pregnant.
- Has a history of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in-situ of the cervix.
- Has a history of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1 (J0810 Arm A)
Patients coming from J0810 (NCT00727441).
Patients receive GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
|
|
Experimental: Cohort 1 (J0810 Arm B)
Patients coming from J0810 (NCT00727441).
Patients receive IV CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months).
Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
Other Names:
|
|
Experimental: Cohort 1 (J0810 Arm C)
Patients coming from J0810 (NCT00727441).
Patients receive oral CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
Other Names:
|
|
Experimental: Cohort 2 (Vaccine Naive)
Patients receive IV CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months).
Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
Other Names:
|
|
Experimental: Cohort 3 (J1568)
Patients coming from J1568 (NCT02451982).
Patients receive IV CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months).
Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
Other Names:
|
|
Experimental: Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282).
Patients receive IV CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months).
Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
Other Names:
|
|
Experimental: Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410).
Patients receive IV CY and GVAX.
|
Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months).
Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
Other Names:
Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m^2 CY administered IV on day 0 of each Cycle (every 6 months).
Cohort 2 patients will receive 200mg/m^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Time Frame: 121 Months
|
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
|
121 Months
|
|
Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)
Time Frame: 121 months
|
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
|
121 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease Free Survival (DFS)
Time Frame: 131 months
|
DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death.
Disease status was monitored by radiologic scans done per standard of care.
DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis.
Estimation based on the Kaplan-Meier curve.
|
131 months
|
|
Overall Survival (OS)
Time Frame: 174 Months
|
OS was measured as the amount of time from date of surgery until death or end of follow-up.
OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis.
Estimation based on the Kaplan-Meier curve.
|
174 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel Laheru, MD, Johns Hopkins University
Study record dates
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 Major Dates
Study Start (Actual)
April 20, 2010
Primary Completion (Actual)
July 17, 2024
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimated)
March 17, 2010
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 6, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Pancreatic Neoplasms
- Adenocarcinoma
- Organic Chemicals
- Hydrocarbons
- Phosphoramide Mustards
- Nitrogen Mustard Compounds
- Mustard Compounds
- Hydrocarbons, Halogenated
- Phosphoramides
- Organophosphorus Compounds
- Cyclophosphamide
Other Study ID Numbers
- J09100
- NA_00031401 (Other Identifier: JHM IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data entry and analysis is still ongoing.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.