Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pediatric Brain Tumor Consortium
Study ID
NCT03387020
Phase
PHASE1
Status
Completed

Conditions

  • CNS Embryonal Tumor, Not Otherwise Specified
  • Malignant Glioma
  • Recurrent Atypical Teratoid/Rhabdoid Tumor
  • Recurrent Childhood Ependymoma
  • Recurrent Diffuse Intrinsic Pontine Glioma
  • Recurrent Medulloblastoma
  • Refractory Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Ribociclib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, 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. Giving ribociclib and everolimus may work better at treating malignant brain tumors.

Key Dates

Start date
Jan 13, 2018
Status verified
Aug 2021
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020

Study Design

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

Arms

  • Experimental: Treatment (ribociclib, everolimus)
    Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses. Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 before surgery. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 13 courses may continue receiving ribociclib and everolimus every 28 days for up to 13 additional courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose of Ribociclib and Everolimus [ Time Frame: 4 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90026-
Lucile Packard Children Hospital Stanford UniversityPalo AltoCalifornia94304-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
National Cancer Institute Pediatric Oncology BranchBethesdaMaryland20892-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cincinnati Children Hospital Medical CenterCincinnatiOhio45229-
Children Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Pediatric Brain Tumor ConsortiumMemphisTennessee38105-
St. Jude Children Research HospitalMemphisTennessee38105-
Texas Children's Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CALucile Packard Children Hospital Stanford University· Palo Alto, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCChildren's Healthcare of Atlanta· Atlanta, GANational Cancer Institute Pediatric Oncology Branch· Bethesda, MD

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