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Procedure

MRI-Guided Laser Ablation + Chemotherapy for Brain Cancer

Phase 2
Recruiting
Led By Joshua Rubin, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ARM A: Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon, Age 3 to ≤ 21, Karnofsky/Lansky performance status ≥ 60%
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will use MRI and blood tests to develop a way to measure and identify when the blood brain barrier is most disrupted after treatment for brain tumors, in order to improve treatment.

Who is the study for?
This trial is for children and young adults aged 3 to 21 with certain types of brain tumors, including various grades of gliomas. Participants must have a performance status indicating they can carry out daily activities (≥60%), adequate heart, liver, and bone marrow function, and not exceed prior anthracycline therapy limits. Pregnant individuals or those unable to undergo MRI are excluded.Check my eligibility
What is being tested?
The study tests the timing of maximal blood-brain barrier disruption using MRI-guided laser ablation followed by chemotherapy in pediatric patients. The goal is to optimize treatment delivery while minimizing systemic side effects and distinguishing between tumor progression and treatment effects.See study design
What are the potential side effects?
Potential side effects include typical reactions to doxorubicin such as hair loss, nausea, vomiting, mouth sores; etoposide may cause low blood counts leading to infection risk; MRI-guided laser ablation could result in localized pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3 and 21 years old with a brain tumor suitable for surgery and can do most activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Arm A only: Overall survival (OS)
Arm A only: Progression-free survival (PFS)
Arm B only: Progression-free survival (PFS)
+1 more
Secondary outcome measures
Correlation of MR imaging with peritumoral BBB disruption
Predictive value of the peritumoral permeability score for patient outcome as measured by PFS
Serum biomarkers of peritumoral BBB disruption

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (MRI-guided laser ablation, doxorubicin, etoposide)Experimental Treatment5 Interventions
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
Group II: Arm A (MRI-guided laser ablation)Experimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
MRI-guided laser ablation
2015
Completed Phase 2
~60
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,813 Total Patients Enrolled
Joshua Rubin, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
Margaret Shatara, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

MRI-guided laser ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02372409 — Phase 2
Brain Tumor Research Study Groups: Arm B (MRI-guided laser ablation, doxorubicin, etoposide), Arm A (MRI-guided laser ablation)
Brain Tumor Clinical Trial 2023: MRI-guided laser ablation Highlights & Side Effects. Trial Name: NCT02372409 — Phase 2
MRI-guided laser ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02372409 — Phase 2
~5 spots leftby Aug 2030
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