Study on Using Focused Ultrasound and Doxorubicin for Treating Pediatric DIPG by Disrupting the Blood-Brain Barrier

Sponsor: InSightec

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05630209

Provider View

This clinical trial is testing a new method to treat children with Diffuse Intrinsic Pontine Gliomas (DIPG) by using focused ultrasound to temporarily open the blood-brain barrier, allowing the chemotherapy drug Doxorubicin to reach the tumor more effectively.

Patient Parameters

Program Overview

The study aims to test the safety and effectiveness of a new treatment approach for children with DIPG, a type of brain tumor. The treatment involves using a device called Exablate to temporarily open the blood-brain barrier, which normally protects the brain from harmful substances. This allows the chemotherapy drug Doxorubicin to enter the brain and target the tumor. The study will take place at up to three locations in the United States and will involve three treatment cycles, each spaced 4 to 6 weeks apart. Researchers hope to determine if this method is safe and if it can help treat DIPG in children.

Description

This study is designed to test a new treatment for children with a type of brain tumor called Diffuse Intrinsic Pontine Gliomas (DIPG). The treatment uses a technology called Exablate to temporarily open the blood-brain barrier, a protective layer that usually prevents substances from entering the brain. By opening this barrier, the chemotherapy drug Doxorubicin can reach the tumor more effectively. The study will be conducted at up to three sites in the United States and will involve three treatment cycles, each about 4 to 6 weeks apart. The main goals are to see if this approach is safe and if it can help treat DIPG in children.

Eligibility Criteria

Inclusion Criteria

  • Children and young adults aged 5 to 21 years.
  • Diagnosed with DIPG.
  • Completed radiation therapy at least 4 weeks ago but not more than 12 weeks ago.
  • Recent brain scans show no signs of tissue damage or bleeding that would prevent treatment.
  • If brain surgery was done, it must have been at least 14 days ago, and the patient should be fully recovered and stable.
  • If taking steroids, the dose should be stable or decreasing for at least 7 days before starting the study.
  • Neurological condition should be stable or improving for at least 7 days before starting the study.
  • Able to give consent or have a legal guardian who can consent.
  • Able to attend all study visits and expected to live at least 6 months.

Exclusion Criteria

  • Tumor not visible on recent brain scans.
  • Previously participated in other early-phase chemotherapy or targeted therapy trials.
  • Signs of increased pressure in the brain.
  • Cancer has spread to other parts of the body.
  • Has a shunt to drain fluid from the brain.
  • Currently receiving Avastin or increasing doses of steroids.
  • Taking blood thinners or medications that increase bleeding risk.
  • History of bleeding disorders or spontaneous tumor bleeding.
  • High blood pressure for age.
  • Blood vessel disorders in the brain or body.
  • Weakened immune system (except for steroid use to manage brain swelling).
  • Positive HIV status.
  • Active seizures not controlled by medication for at least 4 weeks before treatment.
  • Allergic to MRI contrast agents or ultrasound contrast agents.
  • Cannot take Doxorubicin.
  • Previously received high doses of certain chemotherapy drugs.
  • Poor kidney function.
  • May need certain medications during the study that could interfere with treatment.

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