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

StatusCompleted
PhasePhase 1
Started

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Record History

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  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 1
    v45
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2015 to May 2015
    v44
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2013 to Mar 2014
    • Study completion date: Dec 2014 to Dec 2015
    • Site details revised at 11 of 11 sites
    v43
  5. Lead sponsor: New Approaches to Neuroblastoma Therapy Consortium to Children's Hospital Los Angelesv42 Show 4 more changesShow less
    • Primary completion date: Jun 2010 to Dec 2013
    • Study sites: 15 to 11
    • Study completion date: Dec 2014
    • Study title expanded, about 1 word
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  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 words
    v40
  3. Enrollment target: 30 to 68v39 Show 5 more 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
  4. Re-verified, no change to tracked fieldsv38
  5. Primary completion date: Dec 2008 to Jun 2010
    • Study sites: 12 to 15
    v37
  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
  13. Re-verified, no change to tracked fieldsv25
  14. Eligibility criteria shortened, about 16 words
    • Study description revised
    v24
  15. Study sites: 13 to 12
    • Start date: Dec 2005
    • Eligibility criteria expanded, about 16 words
    • Study description revised
    v23
  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
  28. Enrollment target: 30v10
  29. Collaborators expanded, about 4 wordsv9
  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 words
    v2
  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.
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
(from sponsor)		 Neuroblastoma
Related terms Neuroblastoma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov