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Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 803 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv803
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 19, 2026 to Dec 31, 2025
    • Start date: Oct 18, 2001 to Oct 26, 2001
    v802
  3. Study sites revised (197)v801
  4. Re-verified, no change to tracked fieldsv800
  5. Study sites revised (197)v799
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (197)v798
  2. Re-verified, no change to tracked fieldsv797
  3. Study completion date: Mar 7, 2025 to Mar 19, 2026v796
  4. Study sites revised (197)v795
  5. Re-verified, no change to tracked fieldsv794
  6. Study sites revised (197)v793
  7. Study sites revised (197)v792
  8. Study sites revised (197)v791
  9. Re-verified, no change to tracked fieldsv790
  10. Study sites revised (197)v789
  11. Study sites revised (197)v788
  12. Study completion date: Mar 7, 2025v787
  13. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv785-v786
  14. Study sites revised (197)v784
  15. Re-verified, no change to tracked fieldsv783
  16. Site details revised at 1 of 197 sitesv782
  17. 3 versions Re-verified since Mar 7, 2023, no change to tracked fieldsv779-v781
  18. Study sites revised (197)v778
  19. Re-verified, no change to tracked fieldsv777
  20. Study sites revised (197)v776
  21. Study sites: 198 to 197v775
  22. Study sites: 197 to 198v774
  23. 2 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv772-v773
  24. Study sites revised (197)v771
  25. 3 versions Re-verified since Jul 30, 2021, no change to tracked fieldsv768-v770
  26. Study sites revised (197)v767
  27. Re-verified, no change to tracked fieldsv766
  28. Study sites revised (197)v765
  29. Re-verified, no change to tracked fieldsv764
  30. Study sites revised (197)v763
  31. 3 versions Re-verified since Sep 19, 2020, no change to tracked fieldsv760-v762
  32. Study sites revised (197)v759
  33. Study sites revised (197)v758
  34. Study sites revised (197)v757
  35. 2 versions Re-verified since Apr 14, 2020, no change to tracked fieldsv755-v756
  36. Study sites revised (197)v754
  • 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.
This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
Trial Details
NCT Number NCT00026312
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
Related terms Neuroblastoma
Enrollment 1,449 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov