Study on Ropidoxuridine as a Radiation Helper for Newly Diagnosed Glioblastoma with Unmethylated MGMT Promoter

Sponsor: Shuttle Pharmaceuticals, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06359379

Provider View

This clinical trial is testing whether the drug ropidoxuridine can make radiation therapy more effective for patients with a specific type of brain cancer called glioblastoma. The study focuses on patients whose cancer has a particular genetic makeup and who are receiving standard radiation treatment.

Patient Parameters

Program Overview

The study aims to find out if taking the drug ropidoxuridine can help radiation therapy work better in treating a type of brain cancer called glioblastoma. This cancer is newly diagnosed and has specific genetic characteristics. Patients will receive ropidoxuridine along with their regular radiation treatment to see if it improves outcomes.

Description

This study is testing the safety and effectiveness of a drug called ropidoxuridine, which is taken by mouth, to see if it can help radiation therapy work better for patients with a specific type of brain cancer called glioblastoma. This cancer is newly diagnosed and has certain genetic features.

In the first part of the study, 40 patients will be divided into two groups. One group will take a lower dose of ropidoxuridine, and the other will take a higher dose. They will take the drug five days a week for seven weeks, starting one week before their radiation therapy begins. The radiation therapy will be given in small doses over six weeks. After this treatment period, there will be a four-week break.

After the initial treatment, patients may receive additional therapies like temozolomide or other treatments as decided by their doctor. The study will also include MRI scans to monitor the cancer, but these scans will not be used to assess the cancer's progression immediately after radiation due to potential changes caused by the treatment. Regular follow-ups will continue every three months to check for any changes in the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate in the study.
  • Diagnosed with a specific type of brain cancer called glioblastoma, with certain genetic features.
  • Must be eligible for standard radiation therapy.
  • Must have a good overall health status.
  • Must have adequate kidney, liver, and bone marrow function based on specific blood tests.
  • Must have a life expectancy of at least 12 weeks.
  • Must have recovered from any recent surgery and be on a stable dose of steroids if needed.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after.
  • Men must agree to use effective birth control during the study and for 120 days after.

Exclusion Criteria

  • Have received any prior treatment for glioblastoma, except for steroid therapy.
  • Have another active cancer that requires treatment within six months.
  • Have taken any experimental treatments within 28 days before starting the study.
  • Are using medications that reduce stomach acid.
  • Are unable to follow the study procedures.
  • Are pregnant or breastfeeding.
  • Have difficulty swallowing pills or have a digestive disorder that affects drug absorption.
  • Have an active infection requiring treatment, unless it is well-controlled with medication.
  • Have any medical condition that the study doctor believes would make participation unsafe.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.