Trial Outcomes & Findings for Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer (NCT NCT03848182)
NCT ID: NCT03848182
Last Updated: 2024-04-18
Results Overview
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.
TERMINATED
PHASE2
10 participants
Day 1
2024-04-18
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Blood samples were collected and analyzed from 10 patients by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD4 T Cell Responses Before TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
PRIMARY outcome
Timeframe: Day 8Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD4 T Cell Responses Before TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
PRIMARY outcome
Timeframe: Day 15Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD4 T Cell Responses After TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
PRIMARY outcome
Timeframe: Day 28Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD4 T Cell Responses After TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
SECONDARY outcome
Timeframe: Day 1Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD8 T Cell Responses Before TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
SECONDARY outcome
Timeframe: Day 8Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD8 T Cell Responses Before TT Booster Vaccine
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
SECONDARY outcome
Timeframe: Day 15Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD8 T Cell Responses After TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
SECONDARY outcome
Timeframe: Day 28Population: Blood samples were collected and analyzed by flow cytometry as well as by ELISPOT.
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.
Outcome measures
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 Participants
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 and every 28 days
TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
|
|---|---|
|
Change in CD8 T Cell Responses After TT Booster
|
NA cells/uL
Standard Deviation NA
Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8Population: MDSC data was not collected or analyzed for this study.
Outcome measures
Outcome data not reported
Adverse Events
Gemcitabine With TT Vaccine Booster
Serious adverse events
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 participants at risk
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
|
|---|---|
|
Hepatobiliary disorders
Gallbladder Perforation
|
10.0%
1/10 • Number of events 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
|
|
Gastrointestinal disorders
Duodenal Hemorrhage
|
10.0%
1/10 • Number of events 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
|
Other adverse events
| Measure |
Gemcitabine With TT Vaccine Booster
n=10 participants at risk
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
|
|---|---|
|
General disorders
Fatigue
|
50.0%
5/10 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • 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
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 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
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • 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
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • 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
|
|
Gastrointestinal disorders
Abdominal Pain
|
80.0%
8/10 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • 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
|
|
Cardiac disorders
Chest Pain
|
20.0%
2/10 • 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
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • 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
|
|
General disorders
Edema Limbs
|
10.0%
1/10 • 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
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10 • 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
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
50.0%
5/10 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • 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
|
|
Metabolism and nutrition disorders
Poor Appetite
|
50.0%
5/10 • 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
|
|
Investigations
Weight Loss
|
40.0%
4/10 • 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
|
|
General disorders
Gait Disturbance
|
30.0%
3/10 • 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
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
1/10 • 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
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • 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
|
|
Blood and lymphatic system disorders
Spleen Disorder
|
10.0%
1/10 • 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
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.0%
3/10 • 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
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • 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
|
|
Nervous system disorders
Paraesthesia
|
20.0%
2/10 • 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
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • 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
|
|
Nervous system disorders
Sleep Disturbance
|
10.0%
1/10 • 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
|
|
Ear and labyrinth disorders
Hearing Impaired
|
10.0%
1/10 • 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
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • 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
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 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
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
20.0%
2/10 • 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
|
|
General disorders
Pain (general)
|
20.0%
2/10 • 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
|
|
Gastrointestinal disorders
Blood in Stool
|
10.0%
1/10 • 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
|
|
Vascular disorders
Thromboembolic Event
|
10.0%
1/10 • 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
|
Additional Information
Dr. Jennifer Chuy, Co-Investigator, Assistant Professor (Oncology)
Montefiore Medical Center; 1695 Eastchester Road
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place