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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00031401 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| The Skip Viragh Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (J0810 Arm A) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive GVAX. |
|
| Cohort 1 (J0810 Arm B) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX. |
|
| Cohort 1 (J0810 Arm C) | Experimental | Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX. |
|
| Cohort 2 (Vaccine Naive) | Experimental | Patients receive IV CY and GVAX. |
|
| Cohort 3 (J1568) | Experimental | Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX. |
|
| Cohort 4 (J15237) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 121 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 131 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Laheru, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
Data entry and analysis is still ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (J0810 Arm A) | Patients coming from J0810 (NCT00727441) Patients receive GVAX GVAX Pancreas Vaccine: 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). |
| FG001 | Cohort 1 (J0810 Arm B) | Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX Cyclophosphamide (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). GVAX Pancreas Vaccine: 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). |
| FG002 | Cohort 1 (J0810 Arm C) | Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX Cyclophosphamide Pill: 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 Vaccine: 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). |
| FG003 | Cohort 2 (Vaccine Naive) | Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| FG004 | Cohort 3 (J1568) | Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| FG005 | Cohort 4 (J15237) | Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| FG006 | Cohort 5 (J1766) | Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No patients were enrolled into Cohort 4 or Cohort 5
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (J0810 Arm A) | Patients coming from J0810 (NCT00727441) Patients receive GVAX GVAX Pancreas Vaccine: 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | No patients were enrolled into Cohort 4 or Cohort 5 | Posted | Count of Participants | Participants | 121 Months |
|
Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (J0810 Arm A) | Patients coming from J0810 (NCT00727441) Patients receive GVAX GVAX Pancreas Vaccine: 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Laheru, MD | SKCCC Johns Hopkins Medical Institution | 410-955-8974 | Laherda@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2024 | Jun 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
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| Experimental |
Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX. |
|
| Cohort 5 (J1766) | Experimental | Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX. |
|
|
|
| Cyclophosphamide Pill | Drug | 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 Vaccine | Biological | 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). |
|
|
| 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. | 174 Months |
| Cohort 1 (J0810 Arm B) |
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| BG002 | Cohort 1 (J0810 Arm C) | Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX Cyclophosphamide Pill: 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 Vaccine: 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). |
| BG003 | Cohort 2 (Vaccine Naive) | Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| BG004 | Cohort 3 (J1568) | Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| BG005 | Cohort 4 (J15237) | Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| BG006 | Cohort 5 (J1766) | Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: 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).
GVAX Pancreas Vaccine: 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).
| OG002 | Cohort 1 (J0810 Arm C) | Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX Cyclophosphamide Pill: 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 Vaccine: 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). |
| OG003 | Cohort 2 (Vaccine Naive) | Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| OG004 | Cohort 3 (J1568) | Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| OG005 | Cohort 4 (J15237) | Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
| OG006 | Cohort 5 (J1766) | Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). |
|
|
| Primary | 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 | No patients were enrolled into Cohort 4 or Cohort 5 | Posted | Count of Participants | Participants | 121 months |
|
|
|
| Secondary | 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. | Not Posted | Jul 2026 | 131 months | Participants |
| Secondary | 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. | Not Posted | Jul 2026 | 174 Months | Participants |
| 6 |
| 8 |
| 1 |
| 8 |
| 7 |
| 8 |
| EG001 | Cohort 1 (J0810 Arm B) | Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Cohort 1 (J0810 Arm C) | Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX Cyclophosphamide Pill: 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 Vaccine: 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). | 1 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Cohort 2 (Vaccine Naive) | Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). | 37 | 52 | 8 | 52 | 52 | 52 |
| EG004 | Cohort 3 (J1568) | Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). | 3 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Cohort 4 (J15237) | Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Cohort 5 (J1766) | Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX Cyclophosphamide: 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). GVAX Pancreas Vaccine: 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Cholongitis | Hepatobiliary disorders | CTCAE version 3.0 | Systematic Assessment |
|
| FibroInflammatory lesion (pancreas) | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Subacute Peritoneal Infection | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
|
| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Vomiting | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Weight Loss | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Chills | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Edema Limb | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Flu-like Syndrome | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| COVID infection | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Creatinine Increase | Investigations | CTCAE version 3.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Edema Face | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Edema Tunk | General disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Voice Changes | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Muscle Pull | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |