Clinical Trials Logo
  1. Home
  2. Medulloblastoma, Childhood
  3. NCT04167618

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

Medulloblastoma, Childhood Clinical Trial

Official 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04167618
Study type Interventional
Source Y-mAbs Therapeutics
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date September 30, 2021
Completion date August 11, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03288168 - Children's and Adolescents' Medulloblastoma Molecular Subgroups in China
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1
Recruiting NCT04174820 - Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition
Completed NCT04860934 - Dual Task Training On Children With Ataxia After Medulloblastoma Resection N/A
Suspended NCT03904862 - Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery Phase 1/Phase 2
Withdrawn NCT01697514 - A Study of LY2940680 in Pediatric Medulloblastoma or Rhabdomyosarcoma Phase 1
Recruiting NCT05230758 - Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour Phase 3
Not yet recruiting NCT05406947 - Establishment and Clinical Application of Risk Classification Model Based on Molecular Typing of Medulloblastoma in Children
Completed NCT02238899 - Multicenter Register for Children and Young Adults With Intracranial Localized Medulloblastoma, CNS-PNET or Ependymoma N/A
Recruiting NCT05057702 - Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma N/A
Recruiting NCT04185038 - Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors Phase 1
Completed NCT04528316 - Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor N/A
Terminated NCT02624388 - Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) Phase 2