Testing the Safety and Tolerability of CX-4945 in Patients with Recurrent Medulloblastoma, With or Without Surgery

Sponsor: Pediatric Brain Tumor Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03904862

Provider View

This study is exploring the safety and effects of a drug called CX-4945 for patients with a type of brain cancer called recurrent SHH medulloblastoma. It includes patients who may or may not have surgery.

Patient Parameters

Program Overview

This clinical trial is testing a drug called CX-4945 (silmitasertib sodium) to see if it is safe and effective for patients with a type of brain cancer known as recurrent SHH medulloblastoma. The study is being conducted in multiple phases to determine the best dose and to understand how the drug behaves in the body. It involves both children and adults, and some participants may undergo surgery as part of the study.

Description

The main goals of this study are to find the safest dose of CX-4945 for children and adults with recurrent SHH medulloblastoma and to understand how the drug affects the body and the cancer. The study is divided into several parts:

  • Phase I: This part focuses on finding the maximum safe dose for children whose bones are still growing. It also looks at how the drug is processed in the body and its effects on the tumor.
  • Phase II: This part tests the safety of a specific dose in adults and older teens whose bones have stopped growing.
  • Surgical Study: This part involves patients who need surgery. It examines how much of the drug reaches the tumor and its effects.

Participants will take the drug twice a day, and the study will adjust doses to find the safest and most effective amount. After treatment, patients will be monitored for up to two years to check their health and the cancer's response.

Inclusion Criteria:

  • Phase I (Children): Must be under 18, with bones still growing, and have a specific type of brain cancer that has returned.
  • Phase II (Adults): Must be over 18 or have stopped growing, with the same type of cancer.
  • Surgical Study: Must need surgery and be able to take the drug before the operation.
  • All participants must have had previous cancer treatments and be in good health to join the study.

Exclusion Criteria:

  • Nursing mothers, due to potential risks to infants.
  • Patients with other serious health conditions or a history of other cancers, unless in remission for 5 years.
  • Patients with certain digestive issues or heart conditions.
  • Patients taking other cancer treatments or specific medications like warfarin or statins.

Eligibility Criteria

Inclusion Criteria

  • Phase I (Children):
    • Must be under 18 years old and still growing.
    • Must have a measurable tumor.
    • Must have a body surface area within specific limits.
  • Phase II (Adults):
    • Must be over 18 or have stopped growing.
    • Must have a measurable tumor.
  • Surgical Study:
    • Must need surgery and be able to take the drug before surgery.
  • All Phases:
    • Must have recurrent SHH medulloblastoma confirmed by specific tests.
    • Must have had previous cancer treatments and recovered from side effects.
    • Must be in good health with stable neurological conditions.
    • Must agree to use birth control during and after the study.
    • Must have a parent or guardian able to consent if under 18.

Exclusion Criteria

  • Nursing mothers.
  • History of other cancers, unless in remission for 5 years.
  • Certain digestive disorders or surgeries.
  • Serious unrelated health conditions.
  • Heart conditions with a QTc interval over 480ms.
  • Taking other cancer treatments or specific drugs like warfarin or statins.

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