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NCT05843253RECRUITINGIRB Ready

Study of Ribociclib and Everolimus in HGG and DIPG

Sponsored by Nationwide Children's Hospital

Quick Self-Assessment

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1 of 108 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target. The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG, including DIPG.

Who Can Participate

TarGeT-A study strata definitions Part1: Initial Feasibility Study for the combination of ribociclib PfOS formulation with everolimus: Enrollment on this cohort will be limited to patients aged \<21 years with primary intracranial localized HGG and DIPG Part 2 * Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata C-D) * Stratum B: Patients with DIPG * Stratum C: Patients with primary thalamic, spinal cord, and/or secondary/radiation-related HGG. * Stratum D: Patients with metastatic/disseminated HGG, multifocal HGG, and/or gliomatosis cerebri who received CSI. Inclusion Criteria: 1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on: 1.1) Age: patients must be โ‰ฅ12 months and โ‰ค39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort only: patients must be \<21 years of age at the time of enrollment on this p

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

108 participants

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Age Range

12 Months - 39 Years

โšง

Gender

ALL

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Sponsor

Nationwide Children's Hospital

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
NOT_YET_RECRUITING

Chicago

Illinois

Location available
View Chicago location page
NOT_YET_RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Ann Arbor

Michigan

Location available
View Ann Arbor location page
NOT_YET_RECRUITING

Durham

North Carolina

Location available
View Durham location page
RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page
RECRUITING

Columbus

Ohio

Location available
View Columbus location page
NOT_YET_RECRUITING

Philadelphia

Pennsylvania

Location available
View Philadelphia location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Brain Cancer Treatment in Aurora?

Join others in Colorado exploring innovative treatment options through clinical research

Brain Cancer Treatment Options in Aurora, Colorado

If you're searching for Brain Cancer treatment in Aurora, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Aurora, Washington D.C., Chicago and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Brain Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Colorado
Now Enrolling
Up to 108 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Brain Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Brain Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Brain Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05843253. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.