OncoMatch/Clinical Trials/NCT04485559
Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
Is NCT04485559 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Everolimus and Trametinib for recurrent world health organization (who) grade ii glioma.
Treatment: Everolimus · Trametinib — This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: chemotherapy
recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy)
Must have received: biologic therapy
recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy)
Must have received: radiation therapy
recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy)
Cannot have received: surgery alone
Participants with LGG who have had surgery alone are not eligible.
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (unsupported); Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment); Hemoglobin >= 8 m/dL (may be supported); International normalized ratio (INR) <= 1.5
Kidney function
Creatinine clearance or radioisotope growth factor receptor (rGFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as specified
Liver function
Bilirubin (sum of conjugated + unconjugated) <= 1.5 x ULN for age; Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) <= 3 x ULN; Serum albumin >= 2 g/dL
Cardiac function
Corrected QT (QTc) interval <= 450 msecs; Left ventricular ejection fraction (LVEF) >= 50%
See inclusion criteria for full details on organ function requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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