MEKTOVI® for Treating Pediatric Adamantinomatous Craniopharyngioma

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05286788

Provider View

This clinical trial is testing the drug MEKTOVI (binimetinib) to see if it can help treat children and young adults with a type of brain tumor called Adamantinomatous Craniopharyngioma (ACP), especially when the tumor has come back after surgery or radiation.

Patient Parameters

Program Overview

MEKTOVI (binimetinib) is a medication taken by mouth that targets specific proteins involved in tumor growth. This study is exploring its use in children and young adults with a brain tumor called Adamantinomatous Craniopharyngioma (ACP) that has returned after treatment. The trial will involve up to 38 participants who will take the medication every 12 hours for four weeks, which is considered one cycle. Treatment can continue for up to two years. The study is open to patients aged over 1 year and under 25 years, with or without previous radiation treatment.

Description

Adamantinomatous Craniopharyngioma (ACP) is a challenging brain tumor in children that currently lacks effective drug treatments. Surgery and radiation are the main options, but they can lead to a poor quality of life, especially if the tumor returns. Recent research suggests that drugs targeting specific pathways in the tumor, like MEKTOVI, might help control ACP.

In this study, up to 38 participants will take MEKTOVI by mouth at a dose of 32 mg/m2 every 12 hours for four weeks, which is one treatment cycle. The treatment can last up to two years, with each cycle lasting 28 days. The trial is conducted at multiple centers and includes two groups: one for patients who have had radiation (18 patients) and one for those who have not (18 patients).

Eligibility Criteria

Inclusion Criteria

  • Age between 12 months and 25 years.
  • Diagnosed with Adamantinomatous Craniopharyngioma (ACP) confirmed by lab tests.
  • Must have a tumor that can be measured.
    • Group 1: Tumor has returned or grown at least 6 months after radiation.
    • Group 2: Tumor can be measured and has not had radiation, but may have had other treatments.
  • Must be in good enough health to participate, with a performance score of 50% or higher.
  • Must have recovered from any previous treatments.
    • At least 7 days since last dose of a biologic agent.
    • At least 42 days since last immunotherapy.
    • At least 21 days since last monoclonal antibody treatment.
    • At least 6 months since last radiation.
    • At least 6 weeks since last surgery.
  • Must have adequate organ function, including:
    • Bone marrow: Enough white blood cells, platelets, and hemoglobin.
    • Kidneys: Good creatinine clearance or low serum creatinine.
    • Liver: Normal bilirubin and liver enzymes.
    • Heart: Normal heart function and QTc interval.
    • Neurological: Stable neurological condition and controlled seizures.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Must agree to use effective birth control during and after the study.
  • Cannot have serious gastrointestinal diseases or be unable to take oral medication.
  • Cannot be on certain medications, including corticosteroids, investigational drugs, or other cancer treatments.
  • Cannot have uncontrolled infections or have received live vaccines recently.
  • Cannot have serious medical conditions that could affect safety or study completion.
  • Cannot have a history of certain infections or organ transplants.
  • Cannot have a history of substance abuse or recent surgery with healing concerns.
  • Cannot have allergies to similar drugs.

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