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NCT00445965 · FLOW

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Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer · Source last updated 2024-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-3F8: Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
    id
    FG000
    title
    131I-3F8
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Enrolled but not treated
    4. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Removed due to progressive disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-3F8: Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
    id
    FG000
    title
    131I-3F8
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Enrolled but not treated
    4. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Removed due to progressive disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        78
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice