Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amir Jazaeri, University of Virginia
ClinicalTrials.gov Identifier:
NCT00091273
First received: September 7, 2004
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary Peritoneal Cavity Cancer
Interventions: Biological: incomplete Freund's adjuvant
Biological: ovarian cancer peptide vaccine
Biological: sargramostim
Biological: tetanus toxoid helper peptide
Procedure: adjuvant therapy

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Arm No text entered.

Participant Flow:   Overall Study
    Single Arm  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Single Arm No text entered.

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 13  
Gender  
[units: participants]
 
Female     9  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures
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1.  Primary:   Safety of the Vaccine   [ Time Frame: Days 1,8,15,22,29,36,43,50 ]

2.  Primary:   Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay   [ Time Frame: Day 22 ]

3.  Secondary:   Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay   [ Time Frame: Days 1,8,15,22,29,36,43,50 and Month 3 ]


  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: Craig L. Slingluff, MD
Organization: University of Virginia
phone: 434-924-1730
e-mail: cls8h@virginia.edu


No publications provided


Responsible Party: Amir Jazaeri, University of Virginia
ClinicalTrials.gov Identifier: NCT00091273     History of Changes
Other Study ID Numbers: 11276, UVACC-OVA3, UVACC-33204
Study First Received: September 7, 2004
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Federal Government