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Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas

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ClinicalTrials.gov Identifier: NCT00084383
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : July 15, 2013
Last Update Posted : July 22, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Biological: GVAX pancreatic cancer vaccine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GVAX Pancreatic Cancer Vaccine
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 60
Completed 13
Not Completed 47
Arm/Group Title GVAX Pancreatic Cancer Vaccine
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  55.0%
>=65 years
27
  45.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
62  (9.375)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
23
  38.3%
Male
37
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.
Time Frame Participants were followed for the duration of the study, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GVAX Pancreatic Cancer Vaccine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: Months
24.8
(21.2 to 31.6)
2.Primary Outcome
Title Disease-free Survival
Hide Description Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.
Time Frame Participants were followed for the duration of the study, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GVAX Pancreatic Cancer Vaccine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: Months
17.3
(14.6 to 22.8)
3.Secondary Outcome
Title To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.
Hide Description The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.
Time Frame Continuous
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GVAX Pancreatic Cancer Vaccine
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
GVAX Pancreatic Cancer Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GVAX Pancreatic Cancer Vaccine
Affected / at Risk (%) # Events
Total   2/60 (3.33%)    
Hepatobiliary disorders   
Pain, Cancer related  1/1 (100.00%)  1
Biliary Obstruction, secondary to progessive disease  1/1 (100.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GVAX Pancreatic Cancer Vaccine
Affected / at Risk (%) # Events
Total   60/60 (100.00%)    
Blood and lymphatic system disorders   
Eosinophils, elevated  17/60 (28.33%)  30
Gastrointestinal disorders   
Nausea  7/60 (11.67%)  8
General disorders   
Chills  11/60 (18.33%)  12
Fatigue  9/60 (15.00%)  11
Fever  11/60 (18.33%)  19
Flu like symptoms  7/60 (11.67%)  13
Musculoskeletal and connective tissue disorders   
Myalgia  10/60 (16.67%)  12
Arthralgia  5/60 (8.33%)  5
Nervous system disorders   
Dizziness  3/60 (5.00%)  4
Headache  5/60 (8.33%)  7
Skin and subcutaneous tissue disorders   
Blister [1]  4/60 (6.67%)  4
Erythema [1]  60/60 (100.00%)  172
Induration [1]  60/60 (100.00%)  171
Pruritis [1]  51/60 (85.00%)  152
Tenderness [1]  55/60 (91.67%)  142
Vaccine site flare [1]  7/60 (11.67%)  12
Rash  7/60 (11.67%)  13
[1]
Localized vaccine site reaction
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: NCT00084383     History of Changes
Other Study ID Numbers: J9988
R01CA088058 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J9988
First Submitted: June 10, 2004
First Posted: June 11, 2004
Results First Submitted: March 1, 2013
Results First Posted: July 15, 2013
Last Update Posted: July 22, 2013