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N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's Hospital Los Angeles to New Approaches to Neuroblastoma Therapy Consortiumv46
  2. Primary endpoints revised (4) Enrollment target: estimated 68 to confirmed 80 · Secondary endpoints shortened, about 28 words · Study arms: 0 to 1v45 Show all 4 changesShow less
    • Enrollment target: estimated 68 to confirmed 80
    • Secondary endpoints shortened, about 28 words
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Dec 2015 to May 2015v44 Show all 2 changesShow less
    • Study completion date changed from estimate of Dec 2015 to May 2015
  4. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Dec 2013 to Mar 2014 · Completion date: Dec 2014 to Dec 2015 · Site details revised at 11 of 11 sitesv43 Show all 4 changesShow less
    • Primary completion date changed from estimate of Dec 2013 to Mar 2014
    • Completion date: Dec 2014 to Dec 2015
    • Site details revised at 11 of 11 sites
  5. Lead sponsor: New Approaches to Neuroblastoma Therapy Consortium to Children's Hospital Los Angeles Primary completion date: Jun 2010 to Dec 2013 · Study sites: 15 to 11 · Completion date: Dec 2014 · 1 morev42 Show all 5 changesShow less
    • Primary completion date: Jun 2010 to Dec 2013
    • Study sites: 15 to 11
    • Completion date: Dec 2014
    • Study title expanded, about 1 word

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Show 40 earlier versionsHide 40 earlier versions
  1. Site contacts updated at 1 of 15 sitesv41
  2. Primary endpoints: 3 to 4 Eligibility criteria shortened, about 35 words · Secondary endpoints: 2 to 3 · Study description expanded, about 16 wordsv40 Show all 4 changesShow less
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 30 to 68 Primary endpoints: 2 to 3 · Interventions: fenretinide lipid matrix (Drug) to fenretinide lipid matrix (Drug), ketoconazole (Drug), laboratory biomarker analysis (Other), pharmacological study (Other) · Eligibility criteria expanded, about 282 words · 2 morev39 Show all 6 changesShow less
    • Primary endpoints: 2 to 3
    • Interventions: fenretinide lipid matrix (Drug) to fenretinide lipid matrix (Drug), ketoconazole (Drug), laboratory biomarker analysis (Other), pharmacological study (Other)
    • Eligibility criteria expanded, about 282 words
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 105 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv38
  5. Primary completion date: Dec 2008 to Jun 2010 Study sites: 12 to 15v37 Show all 2 changesShow less
    • Study sites: 12 to 15
  6. Study Status, Referencesv36
  7. 4 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv32-v35
  8. Interventions: chemotherapy (Procedure), fenretinide lipid matrix (Drug) to fenretinide lipid matrix (Drug)v31
  9. Re-verified, no change to tracked fieldsv30
  10. Primary completion date: Dec 2008v29
  11. 2 versions Re-verified since Dec 6, 2007, no change to tracked fieldsv27-v28
  12. Study sites revised (12)v26 Show moreShow less

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  13. Re-verified, no change to tracked fieldsv25
  14. Eligibility criteria shortened, about 16 words Study description revisedv24 Show all 2 changesShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 13 to 12 Start date: Dec 2005 · Eligibility criteria expanded, about 16 words · Study description revisedv23 Show all 4 changesShow less
    • Start date: Dec 2005
    • Eligibility criteria expanded, about 16 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  16. Site contacts updated at 1 of 13 sitesv22
  17. Re-verified, no change to tracked fieldsv21
  18. Site contacts updated at 1 of 13 sitesv20
  19. Site contacts updated at 1 of 13 sitesv19
  20. Site details revised at 1 of 13 sitesv18
  21. Study sites: 8 to 13v17
  22. Site contacts updated at 2 of 8 sitesv16
  23. Study Status, Eligibilityv15
  24. Re-verified, no change to tracked fieldsv14
  25. Site contacts updated at 2 of 8 sitesv13
  26. Site contacts updated at 2 of 8 sitesv12
  27. Interventions: chemotherapy (Procedure), fenretinide LXS (Drug) to chemotherapy (Procedure), fenretinide lipid matrix (Drug) Study sites revised (8)v11 Show all 2 changesShow less
    • Study sites revised (8)

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  28. Enrollment target: 30v10
  29. Collaborators expanded, about 4 wordsv9 Show moreShow less

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  30. Site contacts updated at 2 of 8 sitesv8
  31. Lead sponsor: National Cancer Institute (NCI) to New Approaches to Neuroblastoma Therapy Consortiumv7
  32. Re-verified, no change to tracked fieldsv6
  33. Study sites: 14 to 8v5
  34. Re-verified, no change to tracked fieldsv4
  35. Site details revised at 5 of 14 sitesv3
  36. Study sites: 1 to 14 Eligibility criteria shortened, about 17 wordsv2 Show all 2 changesShow less
    • Eligibility criteria shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in treating patients with recurrent, refractory, or persistent neuroblastoma.
Trial Details
NCT Number NCT00295919
Lead Sponsor New Approaches to Neuroblastoma Therapy Consortium
Collaborators: National Cancer Institute (NCI)
Conditions Neuroblastoma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov