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Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

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: NCT00773097
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : February 3, 2014
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Risk for Colorectal Cancer
Intervention Biological: MUC1 - Poly ICLC
Enrollment 46
Recruitment Details Patient recruitment took place at the University of Pittsburgh Digestive Disorders Clinic. Start date for enrollment was November 11, 2008 - February 16, 2011
Pre-assignment Details The subjects were excluded if they had a history of a heritable cancer syndrome, autoimmune disease, or a malignancy within 5 years before the enrollment, excluding nonmelanoma skins cancer.
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Period Title: Overall Study
Started 46
Completed 39
Not Completed 7
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             6
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
A total of 39 subjects completed the 52 weeks of the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
  84.8%
>=65 years
7
  15.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
21
  45.7%
Male
25
  54.3%
1.Primary Outcome
Title Number of Participants With Anti Muc-1 Antibody
Hide Description Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description:
MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
39
2.Secondary Outcome
Title Number of Participants With Autoimmune Response to Muc-1 Vaccine
Hide Description Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description:
MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
39
3.Secondary Outcome
Title Number of Participants With Adverse Events Associated With the Study Agent
Hide Description Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
Time Frame 54 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description:
MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
39
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MUC1 Poly-ICLC
Hide Arm/Group Description MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
All-Cause Mortality
MUC1 Poly-ICLC
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
MUC1 Poly-ICLC
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MUC1 Poly-ICLC
Affected / at Risk (%) # Events
Total   39/39 (100.00%)    
General disorders   
Headache *  3/39 (7.69%)  3
Immune system disorders   
Fatigue *  3/39 (7.69%)  3
Skin and subcutaneous tissue disorders   
injection site discomfort/ reddness *  39/39 (100.00%)  39
*
Indicates events were collected by non-systematic assessment
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: Robert E. Schoen ME
Organization: University Pittsburgh
Phone: 412-648-9115
EMail: rschoen@pitt.edu
Layout table for additonal information
Responsible Party: Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00773097    
Other Study ID Numbers: PRO07030214
First Submitted: October 15, 2008
First Posted: October 16, 2008
Results First Submitted: July 17, 2013
Results First Posted: February 3, 2014
Last Update Posted: January 7, 2019