Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12

This study has been terminated.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Harvard Medical School
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00622401
First received: February 14, 2008
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: Dendritic Cell/Tumor Fusion Vaccine
Drug: Interleukin-12

  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
No text entered.

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

Reporting Groups
  Description
Group 1: Dendritic Cell/Tumor Fusion Vaccine Only

Dendritic Cell/Tumor Fusion Vaccine Only

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1

Dendritic Cell/tumor fusion vaccine and low dose IL-12

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Interleukin-12: Given subcutaneously at dose of 30ng/kg

Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I

Dendritic Cell/tumor fusion vaccine and higher dose IL-12

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Interleukin-12: Given subcutaneously at dose of 100ng/kg


Participant Flow:   Overall Study
    Group 1: Dendritic Cell/Tumor Fusion Vaccine Only     Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1     Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I  
STARTED     6     2     0 [1]
COMPLETED     3     0     0  
NOT COMPLETED     3     2     0  
Disease progression prior to treatment                 3                 2                 0  
[1] Never Opened



  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.
Females >18yo with metastatic breast cancer

Reporting Groups
  Description
Group 1: Dendritic Cell/Tumor Fusion Vaccine Only

Dendritic Cell/Tumor Fusion Vaccine Only

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1

Dendritic Cell/tumor fusion vaccine and low dose IL-12

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Interleukin-12: Given subcutaneously at dose of 30ng/kg

Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I

Dendritic Cell/tumor fusion vaccine and higher dose IL-12

Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells

Interleukin-12: Given subcutaneously at dose of 100ng/kg

Total Total of all reporting groups

Baseline Measures
    Group 1: Dendritic Cell/Tumor Fusion Vaccine Only     Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1     Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I     Total  
Number of Participants  
[units: participants]
  6     2     0     8  
Age  
[units: participants]
       
<=18 years     0     0         0  
Between 18 and 65 years     4     2         6  
>=65 years     2     0         2  
Gender  
[units: participants]
       
Female     6     2         8  
Male     0     0         0  
Region of Enrollment  
[units: participants]
       
United States     6     2         8  



  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine   [ Time Frame: 3 years ]

2.  Secondary:   To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   To Determine if Vaccination With DC/Tumor Fusions and rhIL-12 Results in Clinically Measurable Disease Responses.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
In the conduct of the study, it became apparent that the setting of advanced breast cancer with malignant effusions/ascites for vaccine generation was a difficult setting for evaluation of an immune based therapy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Avigan, MD
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-9920
e-mail: davigan@bidmc.harvard.edu



Responsible Party: David Avigan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00622401     History of Changes
Obsolete Identifiers: NCT00731406
Other Study ID Numbers: 03-221
NCI 6040
U01CA062490 ( US NIH Grant/Contract Award Number )
P30CA006516 ( US NIH Grant/Contract Award Number )
Study First Received: February 14, 2008
Results First Received: January 20, 2016
Last Updated: February 16, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Department of Defence
United States: National Cancer Institute