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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| J0810 | |||
| CDR0000600355 | |||
| NA_00015858 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is more effective with or without cyclophosphamide in treating patients with pancreatic cancer.
PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and to see how well it works when given with or without cyclophosphamide in treating patients undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that can be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Patients undergo blood sample collection periodically for correlative laboratory studies, including immune cell analysis. Immune cell analysis includes monitoring the quantitative change of peripheral blood lymphocytes, including regulatory T cells (Tregs), and functional analysis of T-cell immune response. Tumor tissue samples collected at the time of surgery are analyzed for tumor antigens and infiltrating immune cells by immunohistochemistry and quantitative real-time PCR.
After completion of study treatment, patients are followed periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles. |
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| Arm B | Experimental | Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles.. |
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| Arm C | Experimental | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GVAX pancreatic cancer vaccine | Biological | Given intradermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 | 7 years | |
| Amount of T-regulatory Cells (Tregs) and CD4+ and CD8+ Effector T Cells, After Neoadjuvant GVAX Pancreatic Cancer Vaccination. | up to 8 years | |
| Change in the Number and Function of Peripheral Mesothelin-specific CD8+ T Cells and CD4+, FoxP3+, and GITR+ Tregs | Change in the number and function of peripheral mesothelin-specific CD8+ T cells and CD4+, FoxP3+, and GITR+ Tregs after each GVAX pancreatic cancer vaccination when administered alone or in combination with a single dose or metronomic doses of cyclophosphamide. | up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS will be measured from date of randomization until death or end of follow-up (OS will be 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. | 10 years and 7 months |
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DISEASE CHARACTERISTICS:
Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas
Surgically resectable disease (R0 or R1) by spiral CT scan
Candidate for a pancreaticoduodenectomy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A. Laheru, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - GVAX Vaccine Without Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| cyclophosphamide | Drug | Given IV (Arm B), given orally (Arm C) |
|
| Disease Free Survival |
Disease free survival is defined as the time interval from the date of randomization to the date of radiographic evidence of disease recurrence. Estimation based on the Kaplan-Meier curve. |
| 10 years and 7 months |
| FG001 | Arm B - GVAX Vaccine With IV Cyclophosphamide | Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles.. GVAX pancreatic cancer vaccine: Given intradermally Cyclophosphamide: Given IV |
| FG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally Cyclophosphamide: Given orally |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A - GVAX Vaccine Without Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally |
| BG001 | Arm B - GVAX Vaccine With IV Cyclophosphamide | Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles.. GVAX pancreatic cancer vaccine: Given intradermally cyclophosphamide: Given IV (Arm B), given orally (Arm C) |
| BG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral (PO) cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally cyclophosphamide: Given IV (Arm B), given orally (Arm C) |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 | Posted | Count of Participants | Participants | 7 years |
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| Primary | Amount of T-regulatory Cells (Tregs) and CD4+ and CD8+ Effector T Cells, After Neoadjuvant GVAX Pancreatic Cancer Vaccination. | Data was not collected for this outcome measure. | Posted | up to 8 years |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in the Number and Function of Peripheral Mesothelin-specific CD8+ T Cells and CD4+, FoxP3+, and GITR+ Tregs | Change in the number and function of peripheral mesothelin-specific CD8+ T cells and CD4+, FoxP3+, and GITR+ Tregs after each GVAX pancreatic cancer vaccination when administered alone or in combination with a single dose or metronomic doses of cyclophosphamide. | Data was not collected for this outcome measure. | Posted | up to 8 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | OS will be measured from date of randomization until death or end of follow-up (OS will be 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. | Posted | Median | 95% Confidence Interval | months | 10 years and 7 months |
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| Secondary | Disease Free Survival | Disease free survival is defined as the time interval from the date of randomization to the date of radiographic evidence of disease recurrence. Estimation based on the Kaplan-Meier curve. | Posted | Median | 95% Confidence Interval | months | 10 years and 7 months |
|
Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
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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 | Arm A - GVAX Vaccine Without Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine intradermally (ID) on day 1 of Cycle 1 and undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive an additional dose of the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1. Treatment with the vaccine repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally | 0 | 29 | 0 | 29 | 29 | 29 |
| EG001 | Arm B - GVAX Vaccine With IV Cyclophosphamide | Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 additional cycles.. GVAX pancreatic cancer vaccine: Given intradermally cyclophosphamide: Given IV (Arm B), given orally (Arm C) | 1 | 28 | 0 | 28 | 28 | 28 |
| EG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally cyclophosphamide: Given IV (Arm B), given orally (Arm C) | 1 | 30 | 0 | 30 | 30 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment | and administration site conditions |
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| Fatigue | General disorders | Systematic Assessment | and administration site conditions |
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| Fever | General disorders | Systematic Assessment | and administration site conditions |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| White blood cell count decreased | Investigations | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Blister, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin hyperpigmentation, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Induration, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Tenderness, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vaccine site flare | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Warmth, vaccine site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Laheru | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-955-8974 | laherda@jhmi.edu |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally Cyclophosphamide: Given orally |
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| OG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally Cyclophosphamide: Given orally |
|
| OG002 | Arm C | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally cyclophosphamide: Given IV (Arm B), given orally (Arm C) |
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| OG002 | Arm C - GVAX Vaccine With PO Cyclophosphamide | Patients receive GVAX pancreatic cancer vaccine ID on day 1 of Cycle 1 and low-dose oral cyclophosphamide twice daily on days 1-7. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21 (Cycle 2). Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy comprising gemcitabine, fluorouracil or capecitabine, and radiotherapy over 26-28 weeks. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive the vaccine on day 1 and low-dose oral cyclophosphamide twice daily on days 1-7 and 15-21. Treatment with the vaccine and cyclophosphamide repeats every 28 days for 4 additional cycles. GVAX pancreatic cancer vaccine: Given intradermally Cyclophosphamide: Given orally |
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