Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03598244
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • 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
6 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI scan
  • Savolitinib — DRUG
    Given PO
  • X-Ray Imaging — PROCEDURE
    Undergo X-ray imaging

Study Details

This phase I trial studies the side effects and best dose of volitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory). Volitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Nov 27, 2018
Status verified
Apr 2025
Primary completion
Apr 14, 2025
Completion
Apr 14, 2026

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (volitinib)
    Patients receive volitinib PO QD. Treatment repeats every 28 days for up to 39 courses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, X-ray imaging, and MRI scans throughout study.

Primary Outcome Measure

Maximum tolerated dose of volitinib [ Time Frame: Up to 30 days post treatment ]

Locations (11)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Nationwide Children's HospitalColumbusOhio43205-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital Stanford University· Palo Alto, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCLurie Children's Hospital-Chicago· Chicago, ILMemorial Sloan Kettering Cancer Center· New York, NY

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