Clinical trial · Interventional
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
NCT04167618CI-TRIAL-00070241terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business priorities
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medulloblastoma, Childhood | Childhood Medulloblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-DTPA-omburtamab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-DTPA-omburtamab
- description
- Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to two cycles (Part 1) and up to five cycles (Part 2).
- interventionNames
- Drug: 177Lu-DTPA-omburtamab
Primary outcomes (1)
- measure
- Dose Limiting Toxicities (DLTs) Part 1
- timeFrame
- Days 1 through 35 in cycle 1
- description
- Summary of DLTs in DLT evaluable subjects.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.