A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Nationwide Children's Hospital
Study ID
NCT04655404
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Larotrectinib — DRUG
    1. Larotrectinib monotherapy x2 cycles followed by disease evaluation 2. Larotrectinib with or without chemotherapy backbone
  • Larotrectinib surgical — PROCEDURE
    1. Surgical cohort: Larotrectinib x 3-5 days prior to definitive surgery followed by Larotrectinib monotherapy x2 cycles followed by disease evaluation 2. Larotrectinib with or without chemotherapy backbone

Study Details

This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.

Key Dates

Start date
Apr 8, 2021
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2036

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Feasibility Cohort
    Larotrectinib administered PO, BID @100 mg/m2 on a 28-day cycle schedule.
  • Experimental: Surgical Cohort
    Larotrectinib administered PO, BID @100 mg/m2 3-5 days prior to definitive surgery, followed by Larotrectinib administered PO, BID @100 mg/m2 on a 28-day cycle schedule.

Primary Outcome Measure

Disease control rate [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Holly Lindsay, MD
[email protected]
720-777-8314
Children's National Medical CenterWashington D.C.District of Columbia20010
Eugene Hwang, MD
[email protected]
202-476-5046
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Susan Chi, MD
[email protected]
617-632-4386
Duke University Health SystemDurhamNorth Carolina27708
Daniel Landi, MD
[email protected]
919-684-5013
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter de Blank, MD
[email protected]
513-517-2068
Nationwide Children's HospitalColumbusOhio43235
Maryam Fouladi, MD
[email protected]
6147225758
Maryam Fouladi, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Michael J Fisher, MD
[email protected]
215-590-5188
Texas Children's HospitalHoustonTexas77030
Patricia Baxter, MD
[email protected]
832-824-4681
Seattle Children's HospitalSeattleWashington98105
Sarah Leary, MD
[email protected]
206-987-2106

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILDana-Farber Cancer Institute· Boston, MADuke University Health System· Durham, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

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