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A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

NCT03355794 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-01-13

No results posted yet for this study

Summary

In this research study, we want to learn about the safety of the study drugs, ribociclib and everolimus, when given together at different doses after radiation therapy. We also want to learn about the effects, if any, these drugs have on children and young adults with brain tumors.

We are asking people to be in this research study who have been diagnosed with a high grade glioma, their tumor has been screened for the Rb1 protein, and they have recently finished radiation therapy. If a patient has DIPG or a Bi-thalamic high grade glioma, they do not need to have the tumor tissue screened for the Rb1 protein, but do need to have finished radiation therapy.

Tumor cells grow and divide quickly. In normal cells, there are proteins that control how fast cells grow but in cancer cells these proteins no longer work correctly making tumor cells grow quickly. Both study drugs work in different ways to slow down the growth of tumor cells. The researchers think that if the study drugs are given together soon after radiation therapy, it may help improve the effect of the radiation in stopping or slowing down tumor growth.

The study drugs, ribociclib and everolimus, have been approved by the United States Food and Drug Administration (FDA). Ribociclib is approved to treat adults with breast cancer and everolimus is approved for use in adults and children who have other types of cancers. The combination of ribociclib and everolimus has not been tested in children or in people with brain tumors and is considered investigational.

The goals of this study are:

* Find the safest dose of ribociclib and everolimus that can be given together after radiation.
* Learn the side effects (both good and bad) the study drugs have on the body and tumor.
* Measure the levels of study drug in the blood over time.
* Study the changes in the endocrine system that may be caused by the tumor, surgery or radiation.

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Malignant Glioma of Brain
  • High Grade Glioma
  • Bithalamic High Grade Glioma
  • Brainstem Glioma
  • Glioblastoma
  • Anaplastic Astrocytoma

Interventions

DRUG

ribociclib

Oral capsule or liquid formula

DRUG

Everolimus

Oral tablets or dispersible tablets

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2020-07-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases
Companies

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 NCT03355794 on ClinicalTrials.gov