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NCT02372409 · ADVERSE EVENTS

Adverse events

Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors · Source last updated 2024-11-01

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
-Reportable adverse events will be tracked for 30 days following the last day of study treatment for patients in Arm B and for 30 days following the MLA for patients in Arm A. -All-cause mortality will be collected from start of treatment up to 5 years after start of treatment (median length of follow-up 413.5 days, full range 366 days-1801 days).
Other-event reporting threshold
0%

For patients in Arm A, adverse events (of any grade) considered possibly, probably, or definitely related to the MLA need be reported. Adverse events that are possibly, probably, or definitely related to study procedures will be followed until resolution or stabilization of the event. "Stabilization" is defined as remaining at a consistent CTCAE version 4.0 grade of the event for two consecutive assessments. For Arm B, all grade 3 and higher events regardless of attribution are to be reported.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (MRI-guided Laser Ablation)

* MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression

0 / 55 / 50 / 5
Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)

* MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first

0 / 10 / 10 / 1

Group identifiers: EG000: Arm A (MRI-guided Laser Ablation) · EG001: Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fecal incontinence
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Headache
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Paresthesia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Memory impairment
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Confusion
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Social circumstances
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Noise sensitive
    Complete source fields
    description
    For patients in Arm A, adverse events (of any grade) considered possibly, probably, or definitely related to the MLA need be reported. Adverse events that are possibly, probably, or definitely related to study procedures will be followed until resolution or stabilization of the event. "Stabilization" is defined as remaining at a consistent CTCAE version 4.0 grade of the event for two consecutive assessments. For Arm B, all grade 3 and higher events regardless of attribution are to be reported.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      5
      description
      * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * Every 12 weeks (+/- 7 days) for the first year or until disease progression
      id
      EG000
      other Num Affected
      5
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      Arm A (MRI-guided Laser Ablation)
    2. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      * MLA is a minimally invasive laser surgery currently FDA approved for cytoreductive treatment of brain tumors, both primary and metastatic. MLA employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim. * Within 7 days of MLA (range 2-14 days) doxorubicin will be given intravenously on an outpatient basis weekly for 6 weeks at a dose of 25 mg/m\^2 over 5-30 minutes * Following the completion of doxorubin, etoposide 50 mg/m\^2/day will be given orally for 21 days of each 28-day cycle (treatment can continue up to 24 cycles) * Participants will undergo DCE and DSC-MRI imaging at the following time points: * no more than 3 weeks prior to MLA (OPTIONAL) * within approximately 4 days after MLA * 2-4 weeks after MLA * every 8 weeks (+/- 7 days) until 2 years have elapsed or disease progression, whichever comes first
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Arm B (MRI-guided Laser Ablation, Doxorubicin, Etoposide)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fecal incontinence
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Headache
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Paresthesia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Memory impairment
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Confusion
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Social circumstances
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Noise sensitive
    time Frame
    -Reportable adverse events will be tracked for 30 days following the last day of study treatment for patients in Arm B and for 30 days following the MLA for patients in Arm A. -All-cause mortality will be collected from start of treatment up to 5 years after start of treatment (median length of follow-up 413.5 days, full range 366 days-1801 days).

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

    Preserved source evidence · Not medical advice