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NCT03330197 · BASELINE

Baseline characteristics

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG · Source last updated 2025-08-12

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

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      5
    units
    Participants
groups
  1. description
    Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)
    id
    BG000
    title
    Arm 1 - Closed
  2. description
    Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
    id
    BG001
    title
    Arm 2 - Closed
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12.1
          upper Limit
          21.9
          value
          16.1
        2. group Id
          BG001
          lower Limit
          5.7
          upper Limit
          5.9
          value
          5.8
        3. group Id
          BG002
          lower Limit
          5.7
          upper Limit
          21.9
          value
          12.1
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
    description
    WHO grading of pediatric brain tumors range from Grade 1 (Low Grade) - Slow-growing, to Grade 4 (High Grade) - The most aggressive which grows and spreads rapidly and is difficult to treat. In this study all patients were high grade which means the tumor is already classified as aggressive and likely to spread and come back (recur) after treatment. These tumors have a poorer prognosis (outlook) than low-grade ones.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    WHO High Grade at Baseline
    unit Of Measure
    Participants
population Description
The baseline population includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures. One patient in arm 2 withdrew consent prior to dosing and is considered a screen failure and one patient in Arm 2 only received Ad-RTS-hIL-12 (veledimex was not administered due to a serious adverse event.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      5
    units
    Participants
groups
  1. description
    Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)
    id
    BG000
    title
    Arm 1 - Closed
  2. description
    Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
    id
    BG001
    title
    Arm 2 - Closed
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12.1
          upper Limit
          21.9
          value
          16.1
        2. group Id
          BG001
          lower Limit
          5.7
          upper Limit
          5.9
          value
          5.8
        3. group Id
          BG002
          lower Limit
          5.7
          upper Limit
          21.9
          value
          12.1
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
    description
    WHO grading of pediatric brain tumors range from Grade 1 (Low Grade) - Slow-growing, to Grade 4 (High Grade) - The most aggressive which grows and spreads rapidly and is difficult to treat. In this study all patients were high grade which means the tumor is already classified as aggressive and likely to spread and come back (recur) after treatment. These tumors have a poorer prognosis (outlook) than low-grade ones.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    WHO High Grade at Baseline
    unit Of Measure
    Participants
population Description
The baseline population includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures. One patient in arm 2 withdrew consent prior to dosing and is considered a screen failure and one patient in Arm 2 only received Ad-RTS-hIL-12 (veledimex was not administered due to a serious adverse event.

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

Preserved source evidence · Not medical advice