Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021) (NCT04485559)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high-grade glioma (HGG) (WHO grade III-VI)
2. Participants with LGG who have had surgery alone are not eligible.
3. Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected
4. Participants with spinal cord primaries or disseminated disease are eligible
5. For enrollment, snap frozen tissue (150 mg) or 10 unstained 10 um formalin-fixed, paraffin-embedded (FFPE) slides for comprehensive genomic testing or results of prior testing is required
6. If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs
7. Participants must have evaluable disease
8. Prior therapy: Participants must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, biologics, immunotherapy, or radiotherapy prior to entering this study
9. Myelosuppressive chemotherapy: Participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if they had received nitrosourea. Biologic agents: Participant must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent \>= 7 days prior to study registration. For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration
10. Participants may have received prior treatment with a mitogen-activated extracellular signal-regulated kinase (MEK) or Mechanistic target of rapamycin (mTOR) inhibitor but must not have developed severe (grade III or IV) clinically significant toxicity. (Participants who developed grade III or IV toxicity which was not presumed by the treating physician to be medically significant should be discussed with the study chair or co-chair)
11. Monoclonal antibody treatment: Participants must have received their last dose at least four weeks prior to study registration
12. Radiation: Participants must have: had their last fraction of local irradiation to the primary tumor, craniospinal irradiation (\> 24 Gy) or total body irradiation \> 12 weeks prior to registration; investigators are reminded to review potentially eligible cases to confirm disease progression and avoid confusion with pseudo-progression

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

• University of Alabama at Birmingham, Children's of Alabama — Birmingham, Alabama
• Children's Hospital Los Angeles — Los Angeles, California
• University of California, San Diego Rady Children's Hospital — San Diego, California
• University of California, San Francisco — San Francisco, California
• Children's National Medical Center — Washington D.C., District of Columbia
• University of Florida — Gainesville, Florida
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
• Riley Hospital for Children — Indianapolis, Indiana
• John Hopkins University — Baltimore, Maryland
• Dana Farber Cancer Institute — Boston, Massachusetts
• Children's Minnesota — Minneapolis, Minnesota
• Washington University in St. Louis — St Louis, Missouri
• Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center — Hackensack, New Jersey
• New York University — New York, New York
• Doernbecher Children's Hospital Oregon Health & Science University — Portland, Oregon
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• University Of Texas Southwestern Medical Center — Dallas, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.