ACTEMRA® for Treating Pediatric Adamantinomatous Craniopharyngioma

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05233397

Provider View

This clinical trial is testing the use of ACTEMRA (tocilizumab), a medication typically used for arthritis, to treat children with a type of brain tumor called Adamantinomatous Craniopharyngioma (ACP) that has returned or is difficult to remove.

Patient Parameters

Program Overview

The study aims to see if ACTEMRA, a drug used for arthritis, can help treat children with a brain tumor called Adamantinomatous Craniopharyngioma (ACP) that has come back or cannot be fully removed. The trial will involve up to 38 children and young adults, aged 1 to 25, who will receive the drug every two weeks for up to two years. The study will take place at multiple centers and will include patients who have had surgery or radiation, as well as those who have not.

Description

Adamantinomatous Craniopharyngioma (ACP) is a challenging brain tumor in children that currently lacks effective drug treatments. Surgery and radiation are the main treatments but can lead to a poor quality of life, especially if the tumor returns. Recent research suggests that blocking a specific pathway in the tumor cells might help control ACP. This study will test if ACTEMRA, a drug that blocks this pathway, is safe and effective for children with ACP.

Up to 38 patients will receive ACTEMRA at doses based on their weight, similar to doses used for treating a type of arthritis in children. The treatment will be given every two weeks for up to two years. The trial will include two groups: one for patients who have had radiation and one for those who have not. All participants will be between 1 and 25 years old and have ACP that cannot be completely removed by surgery.

Eligibility Criteria

Inclusion Criteria

  • Age: 1 to 25 years old.
  • Diagnosis: Must have a confirmed diagnosis of Adamantinomatous Craniopharyngioma (ACP).
  • Disease Status: Must have measurable ACP.
    • Group 1: ACP that has returned or grown after radiation.
    • Group 2: ACP that has been surgically treated but not with radiation.
  • Performance Level: Must be able to perform daily activities with some assistance if needed.
  • Prior Therapy: Must have recovered from any previous treatments.
  • Organ Function: Must have adequate bone marrow, kidney, liver, and neurological function.
  • Informed Consent: Must agree to participate and sign consent forms.

Exclusion Criteria

  • Pregnancy or Breast-Feeding: Cannot be pregnant or breastfeeding.
  • Gastrointestinal Disease: Cannot have serious digestive system diseases.
  • Concomitant Medications: Cannot be on certain medications like corticosteroids or other cancer treatments.
  • Study Specific: Cannot have uncontrolled infections, recent vaccinations, or other serious health conditions.
  • Cannot have a history of certain infections or organ transplants.
  • Must not have a history of substance abuse or recent surgery.
  • Cannot have allergies to ACTEMRA or similar drugs.

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