Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03330197 · OUTCOME

Best Overall Response by iRANO Criteria

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 Years

What was measured

Best Overall Response was assessed using the immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria.

Analysis population: The Efficacy Evaluable population is defined as all subjects who received at least 1 dose of study drug and had at least one post-treatment tumor assessment.

Groups in this outcome

Arm 1 - Closed

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)

Arm 2 - Closed

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.

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 - Closed3
Arm 2 - Closed2

Reported measurements

Best Tumor Response SD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed0Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed2Not reportedNot reportedNot reportedNot reported
Best Tumor Response PD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed3Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed0Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1 - Closed0Not reportedNot reportedNot reportedNot reported
Arm 2 - Closed1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Best Tumor Response SD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Best Tumor Response PD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Best Overall Response was assessed using the immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria.
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
    OG000
    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
    OG001
    title
    Arm 2 - Closed
param Type
NUMBER
population Description
The Efficacy Evaluable population is defined as all subjects who received at least 1 dose of study drug and had at least one post-treatment tumor assessment.
reporting Status
POSTED
time Frame
2 Years
title
Best Overall Response by iRANO Criteria
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice