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NCT00445965 · OUTCOME

Number of Participants Evaluable for Toxicities

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).

Groups in this outcome

131I-3F8

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
131I-3F878

Reported measurements

Source class 1

Evaluable for toxicities

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
131I-3F877Not reportedNot reportedNot reportedNot reported

Not evaluable for toxicities, participant was not treated

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
131I-3F81Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77
      title
      Evaluable for toxicities
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Not evaluable for toxicities, participant was not treated
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
Toxicities will be assessed via the NCI toxicity criteria (CTC 3.0).
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
    OG000
    title
    131I-3F8
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
1 year
title
Number of Participants Evaluable for Toxicities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice