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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Nationwide Children's Hospital
Study ID
NCT05278208
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anaplastic Ependymoma
  • Embryonal Tumor
  • High Grade Glioma
  • Medulloblastoma
  • Meningioma
  • 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

Eligibility Criteria

Sex
ALL
Age
4 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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)

Key Dates

First listed
Mar 14, 2022
Start date
Nov 21, 2022
Status verified
Oct 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2033

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I-II
    Pediatric patients (4 to \<12 years, Phase I) and adolescent and young adult patients (12 to \</=39 years, Phase II) with recurrent/progressive high-grade central nervous system tumors and meningiomas that express SST2A and demonstrate uptake on DOTATATE PET will receive Lutathera once every 8 weeks (1 cycle) for a total of 4 doses over 8 months Phase I starting dose will be 200 mCi\*(BSA/1.73m2), corresponding to the BSA-adjusted FDA approved adult Lutathera dosing. The first cycle will be used as the DLT period. Once MTD/RP2D is established, an efficacy expansion cohort of up to 10 patients will be opened to determine the preliminary efficacy of MTD/RP2D of Lutathera Phase II patients will receive the adult RP2D of 200 mCi every 8 weeks to determine the anti-tumor activity of Lutathera in this patient population, through evaluation of 6-month PFS as the primary efficacy endpoint. Response will be assessed on imaging (brain/spine MRI and DOTATATE PET) following every 1-2 cycles.

Primary Outcome Measure

Estimate MTD of Lutathera in pediatric CNS patients 4 to <12 years [ Time Frame: up to 8 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter de Blank, MD
[email protected]
513-517-2068
Nationwide Children's HospitalColumbusOhio43235
Margot Lazow, MD
[email protected]
Melinda Triplet
[email protected]
614-722-6039
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Michael J Fisher
[email protected]
12155905188

Find similar trials in Aurora, CO

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By specialty
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By research site
Children's Hospital Colorado· Aurora, COCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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