Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01089101
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Low Grade Glioma
  • Recurrent Childhood Pilocytic Astrocytoma
  • Recurrent Neurofibromatosis Type 1
  • Recurrent Visual Pathway Glioma
  • Refractory Neurofibromatosis Type 1
  • Refractory Visual Pathway Glioma

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Selumetinib — DRUG
    Given PO

Study Details

This phase I/II trial studies the side effects and the best dose of selumetinib and how well it works in treating or re-treating young patients with low grade glioma that has come back (recurrent) or does not respond to treatment (refractory). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jul 7, 2010
Status verified
Mar 2026
Primary completion
Jan 17, 2026
Completion
Mar 18, 2027

Study Design

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

Arms

  • Experimental: Treatment (selumetinib)
    Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience a sustained objective response from selumetinib on the phase I or phase II portions of the trial, and who have completed 2 years of treatment and stopped study drug may be enrolled on the re-treatment study after progression/recurrence. Patients in the re-treatment study may continue treatment indefinitely in the absence of disease progression or unacceptable toxicities. Patients undergo blood sample collection on study.

Primary Outcome Measure

Maximum tolerated dose and recommended phase 2 dose of selumetinib determined by dose-limiting toxicities (phase I) [ Time Frame: 28 days ]

Locations (17)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
UCSF Medical Center-ParnassusSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgia30329-
Children's Memorial Outpatient Center in Lincoln ParkChicagoIllinois60614-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
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, CAUCSF Medical Center-Mount Zion· San Francisco, CAUCSF Medical Center-Parnassus· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DC

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