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

NCT03387020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-08-27

Study results available
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Summary

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.

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

Interventions

DRUG

Everolimus

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Ribociclib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Mariko D. DeWire-Schottmiller, MD · Pediatric Brain Tumor Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-13
Primary Completion
2020-04-01
Completion
2020-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387020 on ClinicalTrials.gov