Pancreatic CancerPhase 2NCT01088789
Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
A Phase 2 study testing Cyclophosphamide, Cyclophosphamide Pill and GVAX Pancreas Vaccine in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cyclophosphamide, Cyclophosphamide Pill and GVAX Pancreas Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2010to Aug 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Cyclophosphamide, Cyclophosphamide Pill, GVAX Pancreas Vaccine
- Keywords
- Adenocarcinoma, Cyclophosphamide, Immunotherapy, Adjuvant, Pancreatic tumor vaccine, GM-CSF, GVAX, Cancer vaccine
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called CY
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).
Cyclophosphamide PillDrug
Also called CY
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).
GVAX Pancreas VaccineBiological
Also called Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (J0810 Arm A) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive GVAX. Receives: Biological: GVAX Pancreas Vaccine |
| Cohort 1 (J0810 Arm B) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Cohort 1 (J0810 Arm C) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX. Receives: Drug: Cyclophosphamide Pill; Biological: GVAX Pancreas Vaccine |
| Cohort 2 (Vaccine Naive) | Experimental | Patients receive IV CY and GVAX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Cohort 3 (J1568) | Experimental | Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Cohort 4 (J15237) | Experimental | Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Cohort 5 (J1766) | Experimental | Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
Measured: 121 Months
Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
Measured: 121 months
Secondary outcomes (2)
Disease Free Survival (DFS)
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.
Measured: 131 months
Overall Survival (OS)
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.
Measured: 174 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study start20 Apr 2010
- Primary completion17 Jul 2024
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Skip Viragh Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel Laheru, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088789
- Sponsor's protocol ID
- J09100
- Other IDs
- NA_00031401
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2010
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data entry and analysis is still ongoing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01088789
- Acronym / sponsor ID
- J09100
- Conditions
- Pancreatic Cancer
- Keywords
- Adenocarcinoma, Cyclophosphamide, Immunotherapy, Adjuvant, Pancreatic tumor vaccine, GM-CSF, GVAX, Cancer vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- The Skip Viragh Foundation
- Study start
- 20 Apr 2010 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (J0810 Arm A) | Experimental | Biological: GVAX Pancreas VaccinePatients coming from J0810 (NCT00727441). Patients receive GVAX. |
| Cohort 1 (J0810 Arm B) | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccinePatients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX. |
| Cohort 1 (J0810 Arm C) | Experimental | Drug: Cyclophosphamide Pill, Biological: GVAX Pancreas VaccinePatients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX. |
| Cohort 2 (Vaccine Naive) | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccinePatients receive IV CY and GVAX. |
| Cohort 3 (J1568) | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccinePatients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX. |
| Cohort 4 (J15237) | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccinePatients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX. |
| Cohort 5 (J1766) | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccinePatients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: CYCohort 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). | Drug | Cohort 1 (J0810 Arm B), Cohort 2 (Vaccine Naive), Cohort 3 (J1568), Cohort 4 (J15237), Cohort 5 (J1766) |
| Cyclophosphamide PillAlso: CYCohort 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). | Drug | Cohort 1 (J0810 Arm C) |
| GVAX Pancreas VaccineAlso: Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-NeoCohort 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). | Biological | Cohort 1 (J0810 Arm A), Cohort 1 (J0810 Arm B), Cohort 1 (J0810 Arm C), Cohort 2 (Vaccine Naive), Cohort 3 (J1568), Cohort 4 (J15237), Cohort 5 (J1766) |
Primary outcome
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
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
2 secondary outcomes
Disease Free Survival (DFS)
Time frame: 131 months
Overall Survival (OS)
Time frame: 174 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data entry and analysis is still ongoing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Laheru, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Cyclophosphamide Pill and GVAX Pancreas Vaccine in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation (time frame: 121 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.