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Trial record 5 of 1607 for:    Pancreatic Cancer | United States

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00727441
Recruitment Status : Active, not recruiting
First Posted : August 4, 2008
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Biological: GVAX pancreatic cancer vaccine
Drug: cyclophosphamide
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm C - GVAX Vaccine With PO Cyclophosphamide
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 29 28 30
Completed 11 6 5
Not Completed 18 22 25
Reason Not Completed
Disease Progression             11             14             17
Eligibility             7             5             7
Death             0             1             1
Physician Decision             0             1             0
Withdrawal by Subject             0             1             0
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm C - GVAX Vaccine With PO Cyclophosphamide Total
Hide Arm/Group Description

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

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)

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 of all reporting groups
Overall Number of Baseline Participants 29 28 30 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  58.6%
15
  53.6%
12
  40.0%
44
  50.6%
>=65 years
12
  41.4%
13
  46.4%
18
  60.0%
43
  49.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 30 participants 87 participants
62.79  (10.83) 64.96  (11.73) 67.97  (9.96) 65.28  (10.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
Female
9
  31.0%
12
  42.9%
16
  53.3%
37
  42.5%
Male
20
  69.0%
16
  57.1%
14
  46.7%
50
  57.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
Hispanic or Latino
0
   0.0%
3
  10.7%
0
   0.0%
3
   3.4%
Not Hispanic or Latino
27
  93.1%
24
  85.7%
30
 100.0%
81
  93.1%
Unknown or Not Reported
2
   6.9%
1
   3.6%
0
   0.0%
3
   3.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 30 participants 87 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.9%
0
   0.0%
1
   3.3%
3
   3.4%
White
25
  86.2%
26
  92.9%
28
  93.3%
79
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   6.9%
2
   7.1%
1
   3.3%
5
   5.7%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm C - GVAX Vaccine With PO Cyclophosphamide
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 29 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.3%
2
   7.1%
4
  13.3%
2.Primary Outcome
Title Amount of T-regulatory Cells (Tregs) and CD4+ and CD8+ Effector T Cells, After Neoadjuvant GVAX Pancreatic Cancer Vaccination.
Hide Description [Not Specified]
Time Frame up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm C - GVAX Vaccine With PO Cyclophosphamide
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Change in the Number and Function of Peripheral Mesothelin-specific CD8+ T Cells and CD4+, FoxP3+, and GITR+ Tregs
Hide Description 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.
Time Frame up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm C - GVAX Vaccine With PO Cyclophosphamide
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description Time from randomization until death.
Time Frame 12 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Progression-free Survival Survival
Hide Description Time from first vaccine until disease recurrence as evidenced by CA19-9 levels and computed tomography (CT) scan, as defined by NCCN guidelines. Estimated using Kaplan-Meier method.
Time Frame 12 years
Outcome Measure Data Not Reported
Time Frame Up to 8 years
Adverse Event Reporting Description Adverse events were collected through protocol defined mechanisms (i.e. regular investigator assessments and regular laboratory testing)
 
Arm/Group Title Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm CArm C - GVAX Vaccine With PO Cyclophosphamide
Hide Arm/Group Description

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

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)

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)

All-Cause Mortality
Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm CArm C - GVAX Vaccine With PO Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   1/28 (3.57%)   1/30 (3.33%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm CArm C - GVAX Vaccine With PO Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A - GVAX Vaccine Without Cyclophosphamide Arm B - GVAX Vaccine With IV Cyclophosphamide Arm CArm C - GVAX Vaccine With PO Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/29 (100.00%)   28/28 (100.00%)   30/30 (100.00%) 
Gastrointestinal disorders       
Nausea   0/29 (0.00%)  9/28 (32.14%)  7/30 (23.33%) 
General disorders       
Chills  [1]  5/29 (17.24%)  0/28 (0.00%)  5/30 (16.67%) 
Fatigue  [1]  11/29 (37.93%)  7/28 (25.00%)  9/30 (30.00%) 
Fever  [1]  7/29 (24.14%)  4/28 (14.29%)  4/30 (13.33%) 
Investigations       
Lymphocyte count decreased   0/29 (0.00%)  6/28 (21.43%)  11/30 (36.67%) 
White blood cell count decreased   2/29 (6.90%)  1/28 (3.57%)  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders       
Myalgia   4/29 (13.79%)  0/28 (0.00%)  2/30 (6.67%) 
Skin and subcutaneous tissue disorders       
Blister, vaccine site   4/29 (13.79%)  3/28 (10.71%)  0/30 (0.00%) 
Skin hyperpigmentation, vaccine site   7/29 (24.14%)  5/28 (17.86%)  3/30 (10.00%) 
Erythema, vaccine site   29/29 (100.00%)  28/28 (100.00%)  30/30 (100.00%) 
Induration, vaccine site   29/29 (100.00%)  26/28 (92.86%)  30/30 (100.00%) 
Pruritus, vaccine site   24/29 (82.76%)  23/28 (82.14%)  24/30 (80.00%) 
Tenderness, vaccine site   23/29 (79.31%)  18/28 (64.29%)  19/30 (63.33%) 
Hives   4/29 (13.79%)  3/28 (10.71%)  0/30 (0.00%) 
Vaccine site flare   5/29 (17.24%)  0/28 (0.00%)  0/30 (0.00%) 
Warmth, vaccine site   15/29 (51.72%)  17/28 (60.71%)  17/30 (56.67%) 
Indicates events were collected by systematic assessment
[1]
and administration site conditions
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Laheru
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8974
EMail: laherda@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00727441     History of Changes
Other Study ID Numbers: J0810
P30CA006973 ( U.S. NIH Grant/Contract )
J0810
CDR0000600355
NA_00015858 ( Other Identifier: JHM IRB )
First Submitted: August 1, 2008
First Posted: August 4, 2008
Results First Submitted: May 16, 2019
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019