Focused ultrasound using oral etoposide for Diffuse Intrinsic Pontine Glioma

Columbia University Irving Medical Center, New York, NY
Diffuse Intrinsic Pontine Glioma+7 More ConditionsFocused ultrasound with neuro-navigator-controlled sonication - Device
Eligibility
4 - 21
All Sexes
What conditions do you have?
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Study Summary

This trial will assess whether FUS can safely open the blood brain barrier, allowing a greater concentration of the drug to reach into the brain tumor, potentially improving response and reducing side effects.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Intrinsic Pontine Glioma (DIPG)
  • Diffuse Midline Glioma, H3 K27M-Mutant

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Treatment will consist of up to 4 cycles, each lasting 28 days. During the first 2 weeks of each cycle, subjects will receive FUS therapy for a maximum of 3 times per week, concurrent with etoposide.

Week 2
Number of patients with successful opening of the blood brain barrier
Month 3
3-month Overall Survival (OS3)
3-month Progression Free Survival (PFS3)
Day 90
Blood brain barrier/Tumor imaging changes
Number of total adverse events
Day 90
Number of severe or serious adverse events

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Focused ultrasound using oral etoposide
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Focused ultrasound using oral etoposide · No Placebo Group · Phase 1

Focused ultrasound using oral etoposideExperimental Group · 2 Interventions: Focused ultrasound with neuro-navigator-controlled sonication, Etoposide; Oral, 50 Mg · Intervention Types: Device, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: treatment will consist of up to 4 cycles, each lasting 28 days. during the first 2 weeks of each cycle, subjects will receive fus therapy for a maximum of 3 times per week, concurrent with etoposide.

Who is running the clinical trial?

Cheng-Chia (Fred) WuLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
3 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Focused Ultrasound FoundationOTHER
12 Previous Clinical Trials
343 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
3 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Cheng-Chia Wu, MD, PhDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
3 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

Age 4 - 21 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Is the age range for this research restricted to adults under 45?

"This clinical trial is enrolling participants between the ages of four and twenty-one." - Anonymous Online Contributor

Unverified Answer

Is there an opportunity for me to join this investigation?

"Potential participants in this study must have diffuse intrinsic pontine glioma and be aged between 4 and 21. The trial is accepting around 10 people on a first come, first served basis." - Anonymous Online Contributor

Unverified Answer

Does this experiment need more participants at present?

"Data published on clinicaltrials.gov reveals that this research endeavour is actively seeking participants, which was first announced March 1st 2023 and last updated February 28th 2023." - Anonymous Online Contributor

Unverified Answer

How many participants have been recruited to partake in this experiment?

"Indeed, the information provided on clinicaltrials.gov suggests that this medical research is currently in search of participants. This experiment was initially shared online on March 1st 2023 and underwent a revision at the end of February 2023. The team behind this trial plans to enrol 10 patients from one site." - Anonymous Online Contributor

Unverified Answer

Has the FDA authorized using oral etoposide for Focused ultrasound treatment?

"Our team's assessment of the safety profile of Focused Ultrasound using oral etoposide is a 1, as it has only been tested in preliminary clinical trials. As such, there is limited data to support its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

What goals are researchers looking to achieve with this experiment?

"The primary purpose of this trial is to establish the number of patients who experience successful permeability of their blood-brain barrier. This will be evaluated approximately 90 days after completion of focused ultrasound treatment. Further, a secondary objective includes 3-month overall survival which refers to the period between initial treatment and death from any cause. To measure this outcome, participants will have follow up visits at intervals ranging from every three to six months or until passing away for whatever reason. An additional aim focuses on imaging changes in regards to the BBB/Tumor and identifying severe or serious adverse events with CTCAE version 5.0 noting that throm" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.