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

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Enrollment target: 38 to 36

    Study Status, Study Design, Participant Flowv36

  2. Minor

    Secondary endpoints: 2 to 1

    Show what changed: Secondary endpoints
    ToNumber Determineof ifParticipants CellularWho andDemonstrated Humorala ImmunityTwo-fold isIncrease Inducedin byInterferon Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF to Correlate Immunologic Response Following Vaccination.Gamma

    Study Status, Outcome Measures, Outcome Measures (Results), Adverse Eventsv35

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v34

  4. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv33

  5. Minor

    Collaborators: 1 to 2

    Show what changed: Collaborators
    Dana-Farber Cancer Institute

    Study Identification, Study Status, Sponsor/Collaboratorsv32

Show 30 earlier versions

  1. Minor

    Completion date: Dec 2022 to Jul 2023

    Study Statusv31

  2. Minor

    Completion date: Dec 2021 to Dec 2022

    Study Statusv30

  3. Minor

    Completion date: Dec 2020 to Dec 2021

    Study arms: 0 to 2

    Study Status, Study Design, Arms and Interventionsv29

  4. Minor

    Completion date: Dec 2019 to Dec 2020

    Study Statusv28

  5. Minor

    2 amendments

    2 re-verifications since 2018-07-23, no change to tracked fields

    v26-v27

  6. Minor

    Completion date: Dec 2016 to Dec 2019

    Study Status, Outcome Measures (Results)v25

  7. Notable

    Primary endpoint revised

    Show what changed: Primary endpoints
    Number of Participants With Adverse Events Associated With and to Investigate the Clinical Impact of Vaccination With Mature DC/Tumor Fusion and GM-CSF of This Patient Population

    Study Status, Outcome Measures, Outcome Measures (Results)v24

  8. Notable

    Primary endpoint revised

    Show what changed: Primary endpoints
    ToNumber Assessof theParticipants ToxicityWith Adverse Events Associated With and to Investigate the Clinical Impact of V [...] Mature DC/Tumor Fusion and GM-CSF of This Patient Population.

    Study Status, Outcome Measures, Outcome Measures (Results)v23

  9. Notable

    Results first posted: Feb 17, 2016

    Enrollment target: estimated 51 to confirmed 38; Secondary endpoints revised (2); Primary endpoint revised

    Show what changed: Secondary endpoints
    To determineDetermine if cellularCellular and humoralHumoral immunityImmunity is inducedInduced by serialSerial vaccinationVaccination withWith DC/tumorTumor fusionFusion cellsCells and GM-CSF to correlateCorrelate immunologicImmunologic responseResponse followingFollowing vaccinationVaccination.
    Show what changed: Primary endpoints
    To assessAssess the toxicityToxicity associatedAssociated withWith and to investigateInvestigate the clinicalClinical impactImpact of vaccinationVaccination withWith matureMature DC/Tumor fusionFusion and GM-CSF of thisThis patientPatient populationPopulation.

    Study Status, Study Design, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv22

  10. Notable

    Primary completion date: Dec 2012 to Dec 2014

    Completion date: Dec 2015 to Dec 2016

    Study Statusv21

  11. Minor

    4 amendments

    4 re-verifications since 2014-09-15, no change to tracked fields

    v17-v20

  12. Notable

    Primary completion date: Dec 2011 to Dec 2012

    Completion date: Dec 2013 to Dec 2015

    Study Statusv16

  13. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v15

  14. Minor

    Completion date: Dec 2012 to Dec 2013

    Study Statusv14

  15. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Completion date: Dec 2011 to Dec 2012; Site details revised

    Study Status, Contacts/Locationsv13

  16. Notable

    Primary completion date: Dec 2010 to Dec 2011

    Completion date: Jun 2011 to Dec 2011

    Study Status, Sponsor/Collaboratorsv12

  17. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  18. Minor

    Primary completion date: Jun 2010 to Dec 2010

    Completion date: Dec 2010 to Jun 2011; Site contact updated

    Study Status, Contacts/Locationsv10

  19. Minor

    Primary completion date: Apr 2010 to Jun 2010

    Completion date: Apr 2010 to Dec 2010

    Study Statusv9

  20. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v8

  21. Minor

    Primary and study completion dates: Oct 2009 to Apr 2010

    Study Statusv7

  22. Minor

    Site contact updated

    Study Status, Contacts/Locationsv6

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v5

  24. Minor

    Primary and study completion dates: Oct 2009

    Secondary endpoints: details revised at 2 of 2 entries

    Study Status, Sponsor/Collaborators, Outcome Measuresv4

  25. Minor

    Secondary endpoints: details revised at 2 of 2 entries

    Site contact updated

    Study Status, Arms and Interventions, Outcome Measures, Contacts/Locationsv3

  26. Minor

    Site contact updated

    Study Status, Study Design, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Trial Details
NCT Number NCT00458536
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: National Cancer Institute (NCI), Dana-Farber Cancer Institute
Conditions Renal Cancer
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov