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| ID | Type | Description | Link |
|---|---|---|---|
| 422247 | Other Grant/Funding Number | Pancreatic Cancer Action Network |
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Slow accrual
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| Name | Class |
|---|---|
| Pancreatic Cancer Action Network | OTHER |
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The investigator is developing an immune therapy against pancreatic cancer. Immune cells, known as "T cells with tumor killing capacity", are involved in this immune therapy. In mice with pancreatic cance there is evidence that one tetanus toxoid (TT) vaccination (that patients receive from childhood) combined with Gemcitabine activates these killer T cells. (Gemcitabine improves T cell responses) These killer T cells are able to destroy tumor cells uploaded with TT protein (such studies are planned in future clinical trials). The goal of this study is to test whether one TT vaccination combined with Gemcitabine treatment activates the same T cells in pancreatic cancer patients.
Treating PDAC patients with gemcitabine and one TT booster Gemcitabine will be delivered as is standard of care. However, doses may be modified by the treating physician based on patient tolerance. Patients diagnosed with PDAC will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT by Dr. Chuy as outlined in Fig 2. Gemcitabine will be administered on days 1, 8, 15 every 28 days, and one booster with the human TT childhood vaccine will be administered on day 8 (there must be 2 hrs between the TT booster and the Gemcitabine treatment). Blood will be drawn just before each Gemcitabine treatment, except on day 8 at least 2 hrs will be needed between the blood draw and Gemcitabine treatment because the TT booster needs to be given just after the blood draw but 2 hrs before the Gemcitabine treatment (Fig 2). Three tubes of 10 mls each with heparinized blood will be needed for the isolation of peripheral blood mononuclear cells (PBMC). Two tubes will be used to analyze the T cells and one tube for analyzing the MDSC. The memory T cells and MDSC will be analyzed in the laboratory of Dr. Gravekamp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine with TT vaccine booster | Experimental | Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine will be administered on days 1, 8, 15 every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in CD4 T Cell Responses Before TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Day 1 |
| Change in CD4 T Cell Responses Before TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Day 8 |
| Change in CD4 T Cell Responses After TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Day 15 |
| Change in CD4 T Cell Responses After TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CD8 T Cell Responses Before TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Myeloid-derived Suppressor Cells | Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Gravekamp, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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Patients diagnosed with PDAC will be treated with Gemcitabine as is standard of care on days 1, 8, 15 every 28 days. On day 8 one booster with the human TT childhood vaccine will be administered.
Blood will be drawn before each Gemcitabine treatment. On day 8, TT booster will be administered immediately after blood draw but at least 2 hours before Gemcitabine treatment. Patients who withdraw on or before Day 8 (before TT treatment) will not be included in data analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine With TT Vaccine Booster | Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients are evaluated as is standard of care for patients receiving gemcitabine chemotherapy
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine With TT Vaccine Booster | Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8 |
| 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 | Change in CD4 T Cell Responses Before TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Blood samples were collected and analyzed from 10 patients by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 1 |
|
Up to 1 month following Gemcitabine administration, for a total of up to 2 months
Adverse events were reported and coded using the Modified NCI Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine With TT Vaccine Booster | Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gallbladder Perforation | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Perforated Gall Bladder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Chuy, Co-Investigator, Assistant Professor (Oncology) | Montefiore Medical Center; 1695 Eastchester Road | 718-405-8505 | jchuy@montefiore.org |
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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 | Nov 11, 2020 | Feb 23, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D052497 | Lipodystrophy, Congenital Generalized |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| TT vaccine booster | Biological | One human TT childhood vaccine booster will be administered on day 8 |
|
|
| Day 28 |
| Day 1 |
| Change in CD8 T Cell Responses Before TT Booster Vaccine | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Day 8 |
| Change in CD8 T Cell Responses After TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Day 15 |
| Change in CD8 T Cell Responses After TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Day 28 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in CD4 T Cell Responses Before TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 8 |
|
|
|
| Primary | Change in CD4 T Cell Responses After TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 15 |
|
|
|
| Primary | Change in CD4 T Cell Responses After TT Booster | The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 28 |
|
|
|
| Secondary | Change in CD8 T Cell Responses Before TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 1 |
|
|
|
| Secondary | Change in CD8 T Cell Responses Before TT Booster Vaccine | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 8 |
|
|
|
| Secondary | Change in CD8 T Cell Responses After TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 15 |
|
|
|
| Secondary | Change in CD8 T Cell Responses After TT Booster | The relative difference in CD8 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD8 counts and report a mean of change on CD8 on its log scale along with its 95% CI. | Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT. | Posted | Mean | Standard Deviation | cells/uL | Day 28 |
|
|
|
| Other Pre-specified | Change in Myeloid-derived Suppressor Cells | MDSC data was not collected or analyzed for this study. | Posted | Day 8 |
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| 10 |
| 10 |
|
| Duodenal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Abdominal Pain, Intermittent Abdominal Pain, Abdominal Discomfort |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Dyspnea, Shortness of Breath |
|
| Chest Pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Chest Pain, Occasional Chest Pain |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema Limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Bilateral Lower Extremity Edema |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Weakness |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Intermittent Cough, Blood-tinged Cough |
|
| Poor Appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Poor Appetite, Poor PO Intake, Appetite Change |
|
| Weight Loss | Investigations | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Weight Loss, Weight Loss (>40lbs in one month) |
|
| Gait Disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Gait Problem |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Neutropenic |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Emesis |
|
| Spleen Disorder | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Thrombocytopenia |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Glucose, uncontrolled |
|
| Paraesthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Numbness of Hands, Numbness in Extremities |
|
| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sleep Disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hearing Impaired | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Hearing Loss |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Term: Burping |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Left Upper Extremity (LUE) Pain; Left Lateral Thigh Pain |
|
| Pain (general) | General disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Left Upper Quadrant (LUQ) Pain; Right Upper Quadrant (RUQ) Pain |
|
| Blood in Stool | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | Verbatim Terms: Deep Vein Thrombosis (DVT) in Right Lower Extremity; Superficial Vein Thrombosis |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008060 | Lipodystrophy |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |