Health Trials

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

ConditionsHigh Grade GliomaMeningiomaEmbryonal TumorMedulloblastomaAnaplastic EpendymomaRecurrent Diffuse Intrinsic Pontine GliomaRecurrent Malignant GliomaRecurrent MedulloblastomaRecurrent Primary Central Nervous System NeoplasmRefractory Diffuse Intrinsic Pontine GliomaRefractory Malignant GliomaRefractory MedulloblastomaRefractory Primary Central Nervous System Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-39
SponsorNationwide Children's Hospital

About this trial

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively.

Funding Source - FDA OOPD (grant number FD-R-0532-01)

Eligibility criteria

Qualifiers

None

Disqualifiers

Screening Criteria

Eligibility Criteria

Phase I Age Patient must be ≥ 4 and <12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.

Phase II Age Patient must be 12 to </=39 years at the time of enrollment.

Trial design

Treatments tested in this trial

  • LUTATHERA® (Lutetium Lu 177 dotatate)

Treatment groups

65 Participants
are divided into 1 treatment group

Locations

4
Children's Hospital Colorado80045, AuroraColorado, United States
Cincinnati Children's Hospital Medical Center45229, CincinnatiOhio, United States
Nationwide Children's Hospital43235, ColumbusOhio, United States
Children's Hospital of Philadelphia19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

Nationwide Children's Hospital

Lead sponsor

Source ClinicalTrials.gov