Study on PLX038 for Brain and Spinal Cord Tumors with MYC or MYCN Gene Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06161519

Provider View

This clinical trial is testing a new drug, PLX038, for treating brain and spinal cord tumors in adults. The study focuses on tumors with specific gene changes (MYC or MYCN) that may drive cancer growth.

Patient Parameters

Program Overview

The study aims to test the effectiveness of a new drug, PLX038, in treating brain and spinal cord tumors in adults. These tumors often have changes in the MYC or MYCN genes, which can make them more aggressive. Participants will receive PLX038 through an IV every 21 days, along with another medication to reduce infection risk. The study will last up to 7 months, with follow-up visits for up to 5 years to monitor health and treatment effects.

Description

This study is exploring a new treatment for brain and spinal cord tumors that have specific gene changes (MYC or MYCN). These changes can make the tumors more aggressive and harder to treat. The drug being tested, PLX038, is designed to target these changes and potentially improve treatment outcomes.

Participants will receive PLX038 through an IV every 21 days. They will also take another medication a few days later to help prevent infections. The treatment will continue for up to 7 months, with regular check-ups and tests to monitor health and the drug's effects. Hair samples and possibly additional tumor samples will be collected during the study.

The study will also look at how the drug is distributed in the body and its effects on the tumor. Participants will be closely monitored for any side effects and changes in their condition. Follow-up visits will continue every few months for up to 5 years to track long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with a confirmed brain or spinal cord tumor.
  • Tumors must have specific gene changes (MYC or MYCN) for some participants.
  • Must have completed any previous treatments like surgery or radiation at least 4 weeks before starting the study.
  • Must have good overall health and organ function, as determined by specific medical tests.
  • Must agree to use effective birth control during the study and for a period after the last dose.
  • Must be able to understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • History of allergic reactions to similar drugs as PLX038.
  • Recent major surgery within 2 weeks before starting the study.
  • Need for certain medications that interact with PLX038.
  • Previous treatment with similar drugs or specific types of radiation.
  • Genetic conditions affecting drug metabolism.
  • Positive for HIV, Hepatitis B, or Hepatitis C.
  • Pregnant or unable to have MRI scans.
  • Other serious health conditions that could interfere with the study.

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