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Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 67 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    2 amendments

    2 re-verifications since 2026-04-01, no change to tracked fields

    v66-v67

  2. Notable

    Primary and study completion dates: May 2026 to May 2027

    Study Statusv65

  3. Minor

    Study Status, Arms and Interventions

    Re-verified, no change to tracked fields

    v64

  4. Minor

    Eligibility criteria shortened, about 2 words

    Show what changed: Eligibility criteria
    [...] ld have elapsed since last dose of chemotherapy. Age >1 year with a determination Determination that radiation safety restrictions during therapy period ca [...]

    Study Status, Arms and Interventions, Eligibilityv63

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v62

Show 44 earlier versions

  1. Minor

    Site contact updated

    Study Status, Contacts/Locationsv61

  2. Minor

    Study Status, Arms and Interventions

    Re-verified, no change to tracked fields

    v60

  3. Notable

    Primary and study completion dates: May 2025 to May 2026

    Eligibility criteria expanded, about 17 words

    Show what changed: Eligibility criteria
    [...] ring therapy period can be implemented. Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cry [...] eserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 C [...]

    Study Status, Arms and Interventions, Eligibilityv59

  4. Minor

    Site contact updated

    Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharingv58

  5. Minor

    Interventions: iobenguane I 131 (Radiation) to iobenguane I 131 (Drug)

    Site contact updated

    Study Identification, Study Status, Oversight, Arms and Interventions, Contacts/Locations, IPDSharingv57

  6. Minor

    2 amendments

    2 re-verifications since 2024-03-08, no change to tracked fields

    v55-v56

  7. Notable

    Primary and study completion dates: May 2023 to May 2025

    Study Statusv54

  8. Minor

    3 amendments

    3 re-verifications since 2022-04-26, no change to tracked fields

    v51-v53

  9. Minor

    Site contact updated

    Study Status, Contacts/Locationsv50

  10. Minor

    Enrollment target: 150 to 200

    Study Status, Study Designv49

  11. Notable

    Primary and study completion dates: May 2022 to May 2023

    Study Statusv48

  12. Notable

    Primary and study completion dates: May 2021 to May 2022

    Study Statusv47

  13. Notable

    Primary and study completion dates: May 2020 to May 2021

    Study Statusv46

  14. Notable

    Primary and study completion dates: May 2019 to May 2020

    Study Statusv45

  15. Notable

    Enrollment target: 80 to 150

    Study Status, Study Designv44

  16. Notable

    Primary and study completion dates: May 2018 to May 2019

    Study Statusv43

  17. Notable

    Primary and study completion dates: May 2017 to May 2018

    Study Statusv42

  18. Minor

    Study description shortened, about 190 words

    Site contact updated

    Show what changed: Study description
    OBJECTIVES: Primary Utilize targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG) in treating patients with recurrent, progressive, or refractory neuroblastoma (NB) or malignant chromaffin cell tumors (CCT). Determine the response rate in patients with NB treated with this re [...]

    Study Identification, Study Status, Study Description, Contacts/Locationsv41

  19. Notable

    Primary and study completion dates: May 2016 to May 2017

    Study Statusv40

  20. Minor

    2 amendments

    2 re-verifications since 2015-07-21, no change to tracked fields

    v38-v39

  21. Notable

    Primary and study completion dates: May 2015 to May 2016

    Eligibility criteria expanded, about 122 words; Study site revised

    Show what changed: Eligibility criteria
    DISEASEInclusion CHARACTERISTICScriteria for NB: DiagnosisPatients must have the diagnosis of 1NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of thePathology) following: Neuroblastomaor (NB) Meets 1 of the following criteria: Histologically confirmed disease Bone marrowBM involvement withplus elevated urinary catecholamines. ProgressiveMust have a history of tumor progression or recurrentrecurrence diseaseor OR failedfailure to achieve a complete response to priorwith standard therapy. MalignantPatients chromaffinmust have MIBG- [...] [...]
    Show what changed: Study sites
    Memorial Sloan- Kettering Cancer Center

    Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locationsv37

  22. Minor

    Study Status

    Re-verified, no change to tracked fields

    v36

  23. Notable

    Primary and study completion dates: May 2014 to May 2015

    Study Statusv35

  24. Minor

    2 amendments

    2 re-verifications since 2013-07-31, no change to tracked fields

    v33-v34

  25. Notable

    Primary and study completion dates: May 2013 to May 2014

    Study Statusv32

  26. Notable

    Enrollment target: 38 to 80

    Primary completion date: Jan 2010 to May 2013; Completion date: May 2013; Secondary endpoints: details revised at 1 of 1 entry; and 4 more

    Show all 8 changes in this update
    • Notable Enrollment target: 38 to 80
    • Notable Primary completion date: Jan 2010 to May 2013
    • Minor Completion date: May 2013
    • Minor Secondary endpoints: details revised at 1 of 1 entry
    • Minor Study description shortened, about 29 words
      Show what changed
      [...] IBG administration and then every 3 months for up to 1 year. PROJECTED ACCRUAL: A total of 23-38 patients (13-28 with recurrent, progressive, or refractory neuroblastoma, 10 with malignant chromaffin cell tumors) will be accrued for this study within 3 years.
    • Minor Site contact updated
    • Minor Collaborators expanded, about 4 words
      Show what changed
      National Cancer Institute (NCI)
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, Referencesv31

  27. Minor

    Study description revised

    Show what changed: Study description
    [...] f iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 21-4 hours on day 0. Patients undergo radiation dosimetry follow [...]

    Study Status, Study Descriptionv30

  28. Minor

    Study description expanded, about 20 words

    Show what changed: Study description
    [...] aiodobenzylguanidine (^131I-MIBG) IV over 2 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 meta [...]

    Study Status, Study Descriptionv29

  29. Minor

    2 amendments

    2 re-verifications since 2009-07-07, no change to tracked fields

    v27-v28

  30. Minor

    Interventions: arsenic trioxide (Drug), iodine I 131 metaiodobenzylguanidine (Radiation) to iobenguane I 131 (Radiation)

    Study description shortened, about 10 words; Study title shortened, about 3 words

    Show what changed: Study description
    OBJECTIVES: Primary Determine the feasibility ofUtilize targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG) combinedin with arsenic trioxide intreating patients with recurrent, progressive, or refractory neuroblastoma (NB) or malignant chromaffin cell tumors (CCT). Determine the toxicity of this regimen in patients with NB. Determine the response rate in patients with NB treated with [...] aiodobenzylguanidine (^131I-MIBG) IV over 2 hours on day 0. PatientsSome alsopatients may receive arsenica trioxidesecond IVdose overof 1iodine I 131 metaiodobenzylguanidine (^131I-4MIBG) [...]
    Show what changed: Study title
    Iodine I 131 Metaiodobenzylguanidine and Arsenic Trioxide in Treating Patients With Recurrent, Progressive, or Refrac [...]

    Study Identification, Study Status, Study Description, Arms and Interventionsv26

  31. Minor

    Site details revised

    Study Status, Contacts/Locationsv25

  32. Minor

    Interventions: arsenic trioxide (Drug), iodine I 131 metaiodobenzylguanidine (Drug) to arsenic trioxide (Drug), iodine I 131 metaiodobenzylguanidine (Radiation)

    Study Status, Arms and Interventionsv24

  33. Minor

    Study Status

    Re-verified, no change to tracked fields

    v23

  34. Notable

    Start date: Jan 2005 to May 2006

    Study Status, Sponsor/Collaboratorsv22

  35. Minor

    2 amendments

    2 re-verifications since 2008-07-23, no change to tracked fields

    v20-v21

  36. Minor

    Study Status, Contacts/Locations

    v19

  37. Minor

    Interventions: arsenic trioxide (Drug), chemotherapy (Procedure), iodine I 131 metaiodobenzylguanidine (Drug), radioisotope therapy (Procedure)… to arsenic trioxide (Drug), iodine I 131 metaiodobenzylguanidine (Drug)

    Study Status, Arms and Interventionsv18

  • 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.
The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.
Trial Details
NCT Number NCT00107289
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Neuroblastoma, Pheochromocytoma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov