A Phase I/II Study of 177Lu-DTPA-Omburtamab in Children and Adolescents with Medulloblastoma

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Full Title

A Phase I/II Dose-escalation and Expansion Cohort Trial of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients with Recurrent or Refractory Medulloblastoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug 177Lu-DTPA-omburtamab that can be given safely in children and adolescents with medulloblastoma that has continued to grow despite treatment. Medulloblastoma is a type of brain cancer. 177Lu-DTPA-omburtamab is made up of a radioactive material and an “antibody” that targets cancer cells. After reaching the cancer cells, the drug delivers radiation to kill those cells.

177Lu-DTPA-omburtamab works by attacking tumor cells covering the brain and spinal cord. It is given through a catheter (thin tube) directly into the brain.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have medulloblastoma that came back or continued to grow despite treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for children and adolescents ages 3-19.

For more information about this study and to ask about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-338

Phase

I/II

Investigator

Farouk Sait, Sameer, MD