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Vaccine Therapy, Cyclophosphamide, and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

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: NCT00305760
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
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: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Cetuximab
Biological: Pancreatic tumor vaccine
Drug: Cyclophosphamide
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 60
Completed 13
Not Completed 47
Arm/Group Title Group 1
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
39
  65.0%
>=65 years
21
  35.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
60  (9.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
24
  40.0%
Male
36
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population
Hide Description [Not Specified]
Time Frame Continuous
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: Adverse Events
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
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Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.

Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.

Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles.

All-Cause Mortality
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Affected / at Risk (%)
Total   12/60 (20.00%) 
General disorders   
Infusion reaction, erbitux  12/60 (20.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab
Affected / at Risk (%)
Total   60/60 (100.00%) 
Blood and lymphatic system disorders   
Lymphopenia  5/60 (8.33%) 
Cardiac disorders   
Hypotension  3/60 (5.00%) 
Gastrointestinal disorders   
Diarrhea  3/60 (5.00%) 
Vomiting  5/60 (8.33%) 
Nausea  12/60 (20.00%) 
General disorders   
Chills  6/60 (10.00%) 
Fatigue  9/60 (15.00%) 
Fever  17/60 (28.33%) 
Flu like symptoms  10/60 (16.67%) 
Musculoskeletal and connective tissue disorders   
Arthragia  6/60 (10.00%) 
Nervous system disorders   
Dizziness  3/60 (5.00%) 
Headache  26/60 (43.33%) 
Skin and subcutaneous tissue disorders   
Blisters  3/60 (5.00%) 
Dry skin  3/60 (5.00%) 
Erythema, vaccine site  56/60 (93.33%) 
Induration, vaccine site  58/60 (96.67%) 
Pruritis, vaccine site  47/60 (78.33%) 
Tenderness, vaccine site  49/60 (81.67%) 
Pruritis, generalized  7/60 (11.67%) 
Rash  35/60 (58.33%) 
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
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00305760     History of Changes
Other Study ID Numbers: J0501
P30CA006973 ( U.S. NIH Grant/Contract )
BMS-CA225247
First Submitted: March 21, 2006
First Posted: March 22, 2006
Results First Submitted: June 18, 2015
Results First Posted: July 15, 2015
Last Update Posted: July 15, 2015