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NCT01189266 · OUTCOME

Incidence of Toxicity During Chemoradiation Therapy

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma · Source last updated 2021-10-28

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
Planned 7 weeks during chemoradiotherapy

What was measured

Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience

Analysis population: All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.

Groups in this outcome

Arm 1, Phase I Vorinostat 180 mg/m^2

Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO

Arm 2, Phase I Vorinostat 230 mg/m^2

Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO

Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2

Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO

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

Analysis denominator · Participants

GroupSource count
Arm 1, Phase I Vorinostat 180 mg/m^26
Arm 2, Phase I Vorinostat 230 mg/m^26
Arm 3, Phase II Evaluation Vorinostat 230 mg/m^265

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Phase I Vorinostat 180 mg/m^25Not reportedNot reportedNot reportedNot reported
Arm 2, Phase I Vorinostat 230 mg/m^22Not reportedNot reportedNot reportedNot reported
Arm 3, Phase II Evaluation Vorinostat 230 mg/m^224Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        24
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      65
    units
    Participants
description
Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
groups
  1. description
    Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    id
    OG000
    title
    Arm 1, Phase I Vorinostat 180 mg/m^2
  2. description
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    id
    OG001
    title
    Arm 2, Phase I Vorinostat 230 mg/m^2
  3. description
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    id
    OG002
    title
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.
reporting Status
POSTED
time Frame
Planned 7 weeks during chemoradiotherapy
title
Incidence of Toxicity During Chemoradiation Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice