Trial record 1 of 1 for:    NCT00773097
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Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00773097
First received: October 15, 2008
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: July 17, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Risk for Colorectal Cancer
Intervention: Biological: MUC1 - Poly ICLC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
MUC1 Poly-ICLC 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.

Participant Flow:   Overall Study
    MUC1 Poly-ICLC  
STARTED     46  
COMPLETED     39  
NOT COMPLETED     7  
Withdrawal by Subject                 1  
Physician Decision                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 39 subjects completed the 52 weeks of the study.

Reporting Groups
  Description
MUC1 Poly-ICLC 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.

Baseline Measures
    MUC1 Poly-ICLC  
Number of Participants  
[units: participants]
  46  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     39  
>=65 years     7  
Gender  
[units: participants]
 
Female     21  
Male     25  



  Outcome Measures
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1.  Primary:   Number of Participants With Anti Muc-1 Antibody   [ Time Frame: 52 weeks ]

2.  Secondary:   Number of Participants With Autoimmune Response to Muc-1 Vaccine   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Participants With Adverse Events Associated With the Study Agent   [ Time Frame: 54 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert E. Schoen ME
Organization: University Pittsburgh
phone: 412-648-9115
e-mail: rschoen@pitt.edu


Publications of Results:

Responsible Party: Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00773097     History of Changes
Other Study ID Numbers: PRO07030214
Study First Received: October 15, 2008
Results First Received: July 17, 2013
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration