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

ConditionsHigh Grade Glioma Meningioma Embryonal Tumor Medulloblastoma Anaplastic Ependymoma Recurrent Diffuse Intrinsic Pontine Glioma Recurrent Malignant Glioma Recurrent Medulloblastoma Recurrent Primary Central Nervous System Neoplasm Refractory Diffuse Intrinsic Pontine Glioma Refractory Malignant Glioma Refractory Medulloblastoma Refractory 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

LUTATHERA® (Lutetium Lu 177 dotatate)
Drug
Lutathera: IV administration maximum dose of 200 mCi once every 8 weeks (one cycle) for total of 4 cycles (8 months)

Treatment groups

65 Participants

are divided into 1 treatment group

Group A: Phase I-IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Estimate MTD of Lutathera in pediatric CNS patients 4 to <12 years

To estimate the maximum tolerated dose (MTD) of Lutathera in pediatric patients between 4 and 12 to \</=39 yearsof age with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET.

Time frame

up to 8 months

Estimate RP2D of Lutathera in pediatric CNS patients 4 to <12 years

To estimate the recommended Phase II dose (RP2D) of Lutathera in pediatric patients between 4 and 12 to \</=39 years of age with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET.

Time frame

up to 8 months

Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in pediatric (4 to <12 yo) CNS patients treated with Lutathera

To define and describe the toxicities of Lutathera in pediatric patients with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. This will include calculating the number of participants with Lutathera-related adverse events as assessed by CTCAE v 5.0

Time frame

up to 2 months

Assess PFS of Lutathera in CNS patients 12 to </=39 years

To assess efficacy, evaluated by 6 month progression-free survival, of treatment with Lutathera in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET

Time frame

up to 6 months

Secondary outcomes

Objective Response Rate of Lutathera in CNS patients 12 to </=39 years

To evaluate the objective response rate of Lutathera in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET.

Time frame

up to 8 months

Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in CNS patients 12 </=39 years treated with Lutathera

To establish the safety and toxicity of Lutathera 200 mCi every 8-week dosing in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. This will include calculating the number of participants with, as well as severity and frequency of, Lutathera-related adverse events as assessed by CTCAE v 5.0

Time frame

up to 8 months

Other outcomes

Anti-tumor activity of Lutathera

Document anti-tumor activity of Lutathera through assessment of ORR, PFS in patients with recurrent or progressive High-Grade CNS tumors or meningiomas

Time frame

up to 8 months

Prevalence of SST2A expression in patients with different high-grade CNS tumors

Describe prevalence and heterogeneity of SST2A expression (IHC) in patients with recurrent or progressive High-Grade CNS tumors or meningiomas

Time frame

up to 8 months

Correlation of SST2A expression with clinical and molecular features in high-grade CNS tumor patients treated with Lutathera

Assess correlation of SST2A expression with uptake on DOTATATE PET, response to Lutathera therapy, and relevant clinical and molecular features within the confines of a Phase I/II study in patients with recurrent or progressive High-Grade CNS tumors or meningiomas treated with Lutathera

Time frame

up to 8 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

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