N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

StatusCompleted
PhasePhase 2
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 Consortiumv49
  2. Re-verified, no change to tracked fieldsv48
  3. Results first posted: Aug 24, 2016v47 Show 7 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date: Dec 2013
    • Interventions: autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Biological), iobenguane I 131… to 131I-MIBG (Radiation), Carboplatin (Drug), Etoposide (Drug), Filgrastim (Biological), Melphalan (Drug), Peripheral blood stem cell infusion…
    • Secondary endpoints revised (3)
    • Primary endpoint revised
    • Study arms: 0 to 1
    • Study title shortened, about 1 word
  4. Primary completion date: Sep 2010 to Dec 2012v46
  5. Lead sponsor: New Approaches to Neuroblastoma Therapy Consortium to Children's Hospital Los Angeles
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    • Study title shortened, about 15 words
    v45
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites revised (15)v44
  2. Site contacts updated at 1 of 15 sitesv43
  3. Re-verified, no change to tracked fieldsv42
  4. Interventions: autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Biological), iodine I 131… to autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Biological), iobenguane I 131…v41
  5. Interventions: autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Drug), iodine I 131… to autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Biological), iodine I 131…v40
  6. Primary completion date: Sep 2010v39
  7. Study sites: 14 to 15v38
  8. Eligibility criteria expanded, about 51 words
    • Study description expanded, about 3 words
    v37
  9. Re-verified, no change to tracked fieldsv36
  10. Study sites: 12 to 14v35
  11. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv33-v34
  12. Interventions: autologous bone marrow transplantation (Procedure), carboplatin (Drug), chemotherapy (Procedure), colony-stimulating factor therapy… to autologous bone marrow transplantation (Procedure), carboplatin (Drug), etoposide (Drug), filgrastim (Drug), iodine I 131…v32
  13. Re-verified, no change to tracked fieldsv31
  14. Site contacts updated at 1 of 12 sitesv30
  15. 3 versions Re-verified since Dec 6, 2007, no change to tracked fieldsv27-v29
  16. Study sites revised (12)v26
  17. Interventions: autologous bone marrow transplantation (Procedure), biological therapy (Procedure), bone marrow ablation with stem cell support… to autologous bone marrow transplantation (Procedure), carboplatin (Drug), chemotherapy (Procedure), colony-stimulating factor therapy…v25
  18. Eligibility criteria shortened, about 9 words
    • Study description shortened, about 1 word
    v24
  19. Study sites: 13 to 12
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 1 word
    v23
  20. Site details revised at 1 of 13 sitesv22
  21. Site contacts updated at 1 of 13 sitesv21
  22. Site details revised at 1 of 13 sitesv20
  23. Study Status, Outcome Measuresv19
  24. Study sites revised (13)v18
  25. Re-verified, no change to tracked fieldsv17
  26. Study Status, Eligibilityv16
  27. Re-verified, no change to tracked fieldsv15
  28. Site contacts updated at 2 of 13 sitesv14
  29. Site contacts updated at 2 of 13 sitesv13
  30. Study sites revised (13)v12
  31. Enrollment target: 50
    • Start date: Sep 2005
    • Study description revised
    • Eligibility criteria expanded, about 1 word
    v11
  32. Collaborators expanded, about 4 wordsv10
  33. Study sites: 14 to 13v9
  34. Lead sponsor: National Cancer Institute (NCI) to New Approaches to Neuroblastoma Therapy Consortiumv8
  35. Study sites: 8 to 14v7
  36. Re-verified, no change to tracked fieldsv6
  37. Trial status: Suspended to Recruiting
    • Study sites: 14 to 8
    • Interventions: autologous bone marrow transplantation (Procedure), biological response modifier therapy (Procedure), bone marrow ablation with stem cell… to autologous bone marrow transplantation (Procedure), biological therapy (Procedure), bone marrow ablation with stem cell support…
    v5
  38. Trial status: Recruiting to Suspended
    • Site details revised at 14 of 14 sites
    v4
  39. Study description revised
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 1 word
    v3
  40. Site contacts updated at 1 of 14 sitesv2
  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: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.
Trial Details
NCT Number NCT00253435
Lead Sponsor New Approaches to Neuroblastoma Therapy Consortium
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Neuroblastoma
Related terms Neuroblastoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov