Trial Outcomes & Findings for Study of CAP1-6D in Patients With Locally Advanced or Surgically Resected Pancreatic Adenocarcinoma (NCT NCT00203892)
NCT ID: NCT00203892
Last Updated: 2014-04-16
Results Overview
T cell frequency (spots per 10\^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value. A positive value indicates an increase from baseline.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
baseline and every 4 weeks on treatment
Results posted on
2014-04-16
Participant Flow
66 patients screened between August 2004 and September 2009
Participant milestones
| Measure |
A: CEA Peptide 10mcg
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
6
|
|
Overall Study
Received at Least 3 Doses of CEA Vaccine
|
5
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
A: CEA Peptide 10mcg
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Study of CAP1-6D in Patients With Locally Advanced or Surgically Resected Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
A: CEA Peptide 10mcg
n=5 Participants
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
n=8 Participants
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
n=6 Participants
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
57.5 years
n=7 Participants
|
61.5 years
n=5 Participants
|
60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Performance Status
0
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Performance Status
1
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and every 4 weeks on treatmentPopulation: The analysis population for the primary outcome included the 14 patients who received at least 3 doses of the CEA vaccine and had a ELISPOT at least at baseline and after the 3rd cycle.
T cell frequency (spots per 10\^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value. A positive value indicates an increase from baseline.
Outcome measures
| Measure |
A: CEA Peptide 10mcg
n=5 Participants
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
n=5 Participants
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
n=4 Participants
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
|---|---|---|---|
|
Maximum T Cell Response From Baseline
|
10.5 spots per 10^4 CD8+ cells
Interval 0.0 to 155.0
|
51.75 spots per 10^4 CD8+ cells
Interval -16.0 to 432.5
|
270.625 spots per 10^4 CD8+ cells
Interval 72.25 to 377.25
|
SECONDARY outcome
Timeframe: participants were followed while they were on study treatment, a median of 8 weeksDose-limited toxicity included Grade 2 or higher hemorrhage or allergic reaction or clinical evidence of autoimmune disease. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v2.0.
Outcome measures
| Measure |
A: CEA Peptide 10mcg
n=5 Participants
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
n=8 Participants
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
n=6 Participants
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
|---|---|---|---|
|
Evidence of Dose Limiting Toxicities of Immunization With Modified CEA (Carcinoembryonic Antigen) Peptide.
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
A: CEA Peptide 10mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
B: CEA Peptide 100 mcg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
C: CEA Peptide 1000mcg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: CEA Peptide 10mcg
n=5 participants at risk
Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
B: CEA Peptide 100 mcg
n=8 participants at risk
Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
C: CEA Peptide 1000mcg
n=6 participants at risk
Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
12.5%
1/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
0.00%
0/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
12.5%
1/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
16.7%
1/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
12.5%
1/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
0.00%
0/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
0.00%
0/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
16.7%
1/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
General disorders
Pain
|
40.0%
2/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
25.0%
2/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
16.7%
1/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
General disorders
Fatigue
|
40.0%
2/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
25.0%
2/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
16.7%
1/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
|
Skin and subcutaneous tissue disorders
Induration
|
0.00%
0/5 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
12.5%
1/8 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
0.00%
0/6 • during study treatment, a median of 8 weeks
Adverse events of grade 2 or higher are reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place