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NCT01189266 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    title
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        44
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Patient refuses further therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        67
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Phase I /II study. Phase I determined Maximum Tolerated Dose between the first 2 treatment arms; zero patients completed therapy. Study was closed, then reopened to accrual. Phase II enrolled an additional 67 patients. Overall, 79 patients were enrolled but only 2 patients completed all 12 cycles of maintenance chemotherapy.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    title
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        44
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Patient refuses further therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      No treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        67
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        65
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Phase I /II study. Phase I determined Maximum Tolerated Dose between the first 2 treatment arms; zero patients completed therapy. Study was closed, then reopened to accrual. Phase II enrolled an additional 67 patients. Overall, 79 patients were enrolled but only 2 patients completed all 12 cycles of maintenance chemotherapy.

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Preserved source evidence · Not medical advice