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177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

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

NCT04167618•Y-mAbs Therapeutics

View on ClinicalTrials.gov

Summary

Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Detailed Description

Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab. Part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177Lu-DTPA-omburtamab at the recommended dose determined in Part 1. End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up to 2 years after last dose.

Eligibility

Age

3 - 19 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of medulloblastoma.
•SHH, Group 3, or Group 4 according to World Health Organisation (WHO) 2016 classification.
•Recurrent (maximum of 2 recurrences for Part 1 and 1 recurrence for Part 2) or refractory to frontline therapy. Prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.
•Have refractory disease, focal or multifocal recurrent disease, or pure leptomeningeal disease. Cytological or radiographic remission is allowed; however, not simultaneously.
•Performance status score of 50 to 100 on Lansky (less than 16 years) or Karnofsky (16 years or older) scales.
•Life expectancy of at least 3 months, as judged by the Investigator.
•Acceptable hematological status and liver and kidney function.

Exclusion Criteria

•Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/cerebrospinal fluid (CSF) flow study.
•Residual disease (nodular or linear) measuring \> 15 mm in the smallest diameter.
•Ventriculoperitoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.
•Grade 4 nervous system disorder. Stable neurological deficits (due to brain tumor or surgery) or hearing loss are allowed.
•Uncontrolled life-threatening infection.
•Received radiation therapy less than 3 weeks prior to the screening visit.
•Received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit.
•Received any prior anti-B7-H3 treatment.
•Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.
•Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.

Locations (10)

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Doernbecher Children's Hospital

Portland, Oregon, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Rigshospitalet, Børneonkologisk afsnit

Copenhagen, Denmark

Princess Máxima

Utrecht, Netherlands

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Sant Joan de Deu de Barcelona

Barcelona, Spain

The Royal Marsden Hospital

London, United Kingdom

Great North Children's Hospital

Newcastle, United Kingdom

Key Dates

Start Date

September 30, 2021

Primary Completion Date

August 11, 2022

Completion Date

August 11, 2022

Last Updated

October 6, 2023

Enrollment

ACTUAL participants

Conditions

Medulloblastoma, Childhood

Interventions

177Lu-DTPA-omburtamab

DRUG

Medulloblastoma Online Video-based Exercise Pilot Study

NCT06898684

Medulloblastoma, Childhood

View study

COMPLETEDNA

Dual Task Training On Children With Ataxia After Medulloblastoma Resection

NCT04860934

Medulloblastoma, ChildhoodChildhood Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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