Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Children's Oncology Group
Study ID
NCT02323880
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Glioma
  • Recurrent Brain Neoplasm
  • Recurrent Childhood Central Nervous System Neoplasm
  • Recurrent Childhood Glioblastoma
  • Recurrent Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Primary Central Nervous System Neoplasm
  • WHO Grade 3 Glioma

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Pharmacological Study — OTHER
    Correlative studies
  • Selinexor — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key Dates

Start date
Oct 30, 2015
Status verified
Jan 2025
Primary completion
Sep 30, 2022
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Treatment (selinexor)
    Patients receive selinexor PO on either a twice weekly (days 1, 3, 8, 10, 15, 17) or once weekly (days 1, 8, 15, and 22) schedule. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Dose Limiting Toxicities of Selinexor [ Time Frame: Up to 28 days ]

Locations (23)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital of Orange CountyOrangeCalifornia92868-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgia30329-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health and Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-
Children's Hospital of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAChildren's Hospital of Orange County· Orange, CAUCSF Medical Center-Mission Bay· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DC

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