Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00458536
First received: April 10, 2007
Last updated: January 20, 2016
Last verified: January 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Cancer
Interventions: Biological: Dendritic Cell Tumor Fusion Vaccine
Drug: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

  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
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Reporting Groups
  Description
Patients Treated With Vaccine Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.

Participant Flow:   Overall Study
    Patients Treated With Vaccine  
STARTED     38  
COMPLETED     19  
NOT COMPLETED     19  
Disease progression prior to treatment                 7  
Unable to make vaccine                 3  
No measurable disease after surgery                 2  
Did not have renal cell carcinoma                 2  
Patient did not have surgery                 1  
Ineligible due to toxicity                 1  
Withdrawal by Subject                 1  
Progressive disease during treatment                 2  



  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
Patients Treated With Vaccine Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.

Baseline Measures
    Patients Treated With Vaccine  
Number of Participants  
[units: participants]
  19  
Age, Customized  
[units: years]
Median (Full Range)
  56  
  (43 to 79)  
Gender  
[units: participants]
 
Female     6  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     19  



  Outcome Measures

1.  Primary:   To Assess the Toxicity Associated With and to Investigate the Clinical Impact of Vaccination With Mature DC/Tumor Fusion and GM-CSF of This Patient Population.   [ Time Frame: 5 years ]

2.  Secondary:   To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   to Correlate Immunologic Response Following Vaccination.   [ Time Frame: 5 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
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  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, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00458536     History of Changes
Other Study ID Numbers: 04-117
Study First Received: April 10, 2007
Results First Received: January 20, 2016
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration