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Virus Therapy

Arm 1 - Closed for Diffuse Intrinsic Pontine Glioma

Phase 1 & 2
Waitlist Available
Research Sponsored by Ziopharm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing a new cancer treatment, Ad-RTS-hIL-12 given with veledimex, to see if it is safe and tolerable in children. This treatment is designed to improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The safety and tolerability of intratumoral Ad-RTS-hIL-12 and veledimex as measured by dose limiting toxicities and compliance.
Secondary outcome measures
Evaluate preliminary efficacy of Ad-RTS-hIL-12 and veledimex by assessing survival and tumor response rates
Measure immune response of Ad-RTS-hIL-12 and veledimex by a quantitative multiplex immunoassay for determination of IL-12 and IFNg levels
Subjects with Ad-RTS-hIL-12 and veledimex related adverse events will be assessed for safety by CTCAE v5.0
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - OpenExperimental Treatment2 Interventions
Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.
Group II: Arm 1 - ClosedExperimental Treatment2 Interventions
Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad-RTS-hIL-12
2015
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

ZiopharmLead Sponsor
35 Previous Clinical Trials
3,997 Total Patients Enrolled
Alaunos TherapeuticsLead Sponsor
40 Previous Clinical Trials
4,221 Total Patients Enrolled
Jill BuckStudy DirectorZIOPHARM Oncology, Inc.
~1 spots leftby Sep 2025
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