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

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Enrollment target: 38 to 36v36
  2. Secondary endpoints: 2 to 1v35
  3. Re-verified, no change to tracked fieldsv34
  4. Trial status: Active, Not Recruiting to Completedv33
  5. Collaborators: 1 to 2v32
Show 30 earlier versionsHide 30 earlier versions
  1. Study completion date: Dec 2022 to Jul 2023v31
  2. Study completion date: Dec 2021 to Dec 2022v30
  3. Study completion date: Dec 2020 to Dec 2021
    • Study arms: 0 to 2
    v29
  4. Study completion date: Dec 2019 to Dec 2020v28
  5. 2 versions Re-verified since Jul 23, 2018, no change to tracked fieldsv26-v27
  6. Study completion date: Dec 2016 to Dec 2019v25
  7. Primary endpoint revisedv24
  8. Primary endpoint revisedv23
  9. Results first posted: Feb 17, 2016
    • Enrollment target: estimated 51 to confirmed 38
    • Secondary endpoints revised (2)
    • Primary endpoint revised
    v22
  10. Primary completion date: Dec 2012 to Dec 2014
    • Study completion date: Dec 2015 to Dec 2016
    v21
  11. 4 versions Re-verified since Sep 15, 2014, no change to tracked fieldsv17-v20
  12. Primary completion date: Dec 2011 to Dec 2012
    • Study completion date: Dec 2013 to Dec 2015
    v16
  13. Re-verified, no change to tracked fieldsv15
  14. Study completion date: Dec 2012 to Dec 2013v14
  15. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2011 to Dec 2012
    • Site details revised
    v13
  16. Primary and study completion dates pushed to Dec 2011v12
  17. Re-verified, no change to tracked fieldsv11
  18. Primary completion date: Jun 2010 to Dec 2010
    • Study completion date: Dec 2010 to Jun 2011
    • Site contact updated
    v10
  19. Primary completion date: Apr 2010 to Jun 2010
    • Study completion date: Apr 2010 to Dec 2010
    v9
  20. Re-verified, no change to tracked fieldsv8
  21. Primary and study completion dates: Oct 2009 to Apr 2010v7
  22. Site contact updatedv6
  23. Re-verified, no change to tracked fieldsv5
  24. Primary and study completion dates: Oct 2009
    • Secondary endpoints: details revised at 2 of 2 entries
    v4
  25. Secondary endpoints: details revised at 2 of 2 entries
    • Site contact updated
    v3
  26. Site contact updatedv2
  1. Study First Submitted
  • 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
(from sponsor)		 Renal Cancer
Related terms Kidney Neoplasms
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov