Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Primary and study completion dates: May 2026 to May 2027v38
  2. Primary and study completion dates: May 2025 to May 2026v37
  3. Re-verified, no change to tracked fieldsv36
  4. Primary and study completion dates: May 2023 to May 2025v35
  5. Re-verified, no change to tracked fieldsv34
Show 32 earlier versionsHide 32 earlier versions
  1. Primary and study completion dates: May 2022 to May 2023v33
  2. Enrollment target: estimated 12 to confirmed 13v32
  3. Primary and study completion dates: May 2021 to May 2022v31
  4. Re-verified, no change to tracked fieldsv30
  5. Primary and study completion dates: May 2020 to May 2021v29
  6. Primary and study completion dates: May 2019 to May 2020v28
  7. Primary and study completion dates: May 2018 to May 2019v27
  8. Primary and study completion dates: May 2017 to May 2018v26
  9. Primary and study completion dates: May 2016 to May 2017v25
  10. Primary and study completion dates: May 2015 to May 2016
    • Study site revised
    v24
  11. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v23
  12. Re-verified, no change to tracked fieldsv22
  13. Primary and study completion dates: May 2014 to May 2015v21
  14. Re-verified, no change to tracked fieldsv20
  15. Primary and study completion dates: May 2013 to May 2014v19
  16. Re-verified, no change to tracked fieldsv18
  17. Primary and study completion dates: May 2012 to May 2013v17
  18. 2 versions Re-verified since May 2, 2011, no change to tracked fieldsv15-v16
  19. Primary and study completion dates: May 2011 to May 2012v14
  20. Re-verified, no change to tracked fieldsv13
  21. Eligibility criteria expanded, about 17 wordsv12
  22. Eligibility criteria expanded, about 4 wordsv11
  23. Primary and study completion dates: May 2010 to May 2011
    • Collaborators shortened, about 4 words
    v10
  24. 2 versions Re-verified since Jan 29, 2009, no change to tracked fieldsv8-v9
  25. Primary and study completion dates: May 2009 to May 2010
    • Eligibility criteria expanded, about 13 words
    v7
  26. Eligibility criteria expanded, about 55 wordsv6
  27. Primary completion date: May 2009v5
  28. Primary endpoints: 5 to 1
    • Study completion date: May 2009
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 0 to 1
    v4
  29. 2 versions Re-verified since Apr 19, 2007, no change to tracked fieldsv2-v3
  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 purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response. The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of the immune system that may also help to fight against tumor cells. One way to make antibodies and stimulate T-cells is to inject the patient with a preparation which contains material that may stimulate the immune system. This process is called an immunization. We are trying to immunize the patient against HER2/neu. In order to participate in this trial, the tumor must have a large amount of HER2/neu on its surface. The injection that the patient will receive in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is material which contains the information needed to produce many substances in the body. The HER2 gene encodes for a protein known as HER2.
Trial Details
NCT Number NCT00393783
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov