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NCT00602667 · OUTCOME

Topotecan AUC0-24h in Consolidation Chemotherapy

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

Measure
MEDIAN
Unit
µg·h/L
Interval / dispersion
Full Range
Time frame
Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion

What was measured

Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.

Analysis population: Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.

Groups in this outcome

Intermediate-Risk Group

Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease

High-Risk Group

Patients with central nervous system (CNS) metastatic disease

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

Analysis denominator · Participants

GroupSource count
Intermediate-Risk Group1
High-Risk Group27

Reported measurements

Source class 1
Values in µg·h/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Intermediate-Risk Group117Not reported117117Not reported
High-Risk Group116Not reported90262Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        117
        upper Limit
        117
        value
        117
      2. group Id
        OG001
        lower Limit
        90
        upper Limit
        262
        value
        116
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.
dispersion Type
Full Range
groups
  1. description
    Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
    id
    OG000
    title
    Intermediate-Risk Group
  2. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG001
    title
    High-Risk Group
param Type
MEDIAN
population Description
Eligible patients who received intravenous topotecan during consolidation cycle 1 and had PK samples collected were included in this analysis. Per protocol, low- and intermediate-risk patients did not receive topotecan during consolidation unless they experienced disease progression during induction. One such intermediate-risk patient was included.
reporting Status
POSTED
time Frame
Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion
title
Topotecan AUC0-24h in Consolidation Chemotherapy
type
SECONDARY
unit Of Measure
µg·h/L

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice