Trial Outcomes & Findings for Vaccine Therapy 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 (NCT NCT00727441)
NCT ID: NCT00727441
Last Updated: 2020-02-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
7 years
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
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
|
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 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
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
30
|
|
Overall Study
COMPLETED
|
11
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
18
|
22
|
25
|
Reasons for withdrawal
| Measure |
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
|
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 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
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
11
|
14
|
17
|
|
Overall Study
Eligibility
|
7
|
5
|
7
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Vaccine Therapy 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
Baseline characteristics by cohort
| Measure |
Arm A - GVAX Vaccine Without Cyclophosphamide
n=29 Participants
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
|
Arm B - GVAX Vaccine With IV Cyclophosphamide
n=28 Participants
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)
|
Arm C - GVAX Vaccine With PO Cyclophosphamide
n=30 Participants
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)
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Continuous
|
62.79 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
64.96 years
STANDARD_DEVIATION 11.73 • n=7 Participants
|
67.97 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
65.28 years
STANDARD_DEVIATION 10.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 yearsOutcome measures
| Measure |
Arm A - GVAX Vaccine Without Cyclophosphamide
n=29 Participants
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
|
Arm B - GVAX Vaccine With IV Cyclophosphamide
n=28 Participants
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 C - GVAX Vaccine With PO Cyclophosphamide
n=30 Participants
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
|
|---|---|---|---|
|
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
|
3 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 8 yearsPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 8 yearsPopulation: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 years and 7 monthsOS 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.
Outcome measures
| Measure |
Arm A - GVAX Vaccine Without Cyclophosphamide
n=29 Participants
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
|
Arm B - GVAX Vaccine With IV Cyclophosphamide
n=28 Participants
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 C - GVAX Vaccine With PO Cyclophosphamide
n=30 Participants
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
|
|---|---|---|---|
|
Overall Survival
|
34.2 months
Interval 21.6 to 45.7
|
15.4 months
Interval 13.2 to 26.5
|
16.5 months
Interval 11.3 to 25.2
|
SECONDARY outcome
Timeframe: 10 years and 7 monthsDisease 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.
Outcome measures
| Measure |
Arm A - GVAX Vaccine Without Cyclophosphamide
n=29 Participants
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
|
Arm B - GVAX Vaccine With IV Cyclophosphamide
n=28 Participants
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 C - GVAX Vaccine With PO Cyclophosphamide
n=30 Participants
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
|
|---|---|---|---|
|
Disease Free Survival
|
18.92 months
Interval 13.87 to 34.1
|
8.54 months
Interval 2.66 to 17.1
|
5.56 months
Interval 3.67 to 14.0
|
Adverse Events
Arm A - GVAX Vaccine Without Cyclophosphamide
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm B - GVAX Vaccine With IV Cyclophosphamide
Serious events: 0 serious events
Other events: 28 other events
Deaths: 1 deaths
Arm C - GVAX Vaccine With PO Cyclophosphamide
Serious events: 0 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A - GVAX Vaccine Without Cyclophosphamide
n=29 participants at risk
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
|
Arm B - GVAX Vaccine With IV Cyclophosphamide
n=28 participants at risk
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)
|
Arm C - GVAX Vaccine With PO Cyclophosphamide
n=30 participants at risk
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)
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
32.1%
9/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
23.3%
7/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
General disorders
Chills
|
17.2%
5/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
16.7%
5/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
General disorders
Fatigue
|
37.9%
11/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
25.0%
7/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
30.0%
9/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
General disorders
Fever
|
24.1%
7/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
10.7%
3/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
13.3%
4/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
21.4%
6/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
36.7%
11/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Investigations
White blood cell count decreased
|
6.9%
2/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
3.6%
1/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
13.3%
4/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
4/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
6.7%
2/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Blister, vaccine site
|
13.8%
4/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
10.7%
3/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation, vaccine site
|
24.1%
7/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
17.9%
5/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
10.0%
3/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Erythema, vaccine site
|
100.0%
29/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
100.0%
28/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
100.0%
30/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Induration, vaccine site
|
100.0%
29/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
92.9%
26/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
100.0%
30/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Pruritus, vaccine site
|
82.8%
24/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
82.1%
23/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
80.0%
24/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Tenderness, vaccine site
|
79.3%
23/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
64.3%
18/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
63.3%
19/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Hives
|
13.8%
4/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
10.7%
3/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Vaccine site flare
|
17.2%
5/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
0.00%
0/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
|
Skin and subcutaneous tissue disorders
Warmth, vaccine site
|
51.7%
15/29 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
60.7%
17/28 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
56.7%
17/30 • Up to 8 years
Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
|
Additional Information
Dr. Daniel Laheru
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place