Study Comparing GLIADEL and Stereotactic Radiosurgery for Treating Brain Tumors from Cancer

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04222062

Provider View

This clinical trial is exploring whether adding GLIADEL, a local chemotherapy, to the site where a brain tumor was removed is as effective as using radiation treatment after surgery to prevent the cancer from returning.

Patient Parameters

Program Overview

The purpose of this study is to find out if using GLIADEL, a type of local chemotherapy, at the site of a removed brain tumor can prevent the cancer from coming back as effectively as using stereotactic radiosurgery (SRS) after surgery. The study involves 100 adults with one to four brain tumors that have spread from other parts of the body. One of these tumors will be surgically removed. Participants will be randomly assigned to either receive GLIADEL during surgery or SRS after surgery. Any other tumors will be treated with SRS after surgery. The study will monitor participants for cancer recurrence and changes in brain function.

Description

This study is testing whether GLIADEL, a local chemotherapy, can prevent brain tumors from returning after surgery as well as stereotactic radiosurgery (SRS). It involves 100 adults with one to four brain tumors that have spread from other cancers. One tumor will be surgically removed. Participants will be randomly assigned to receive either GLIADEL during surgery or SRS after surgery. Any other tumors will be treated with SRS. Participants will have brain scans and tests before and after surgery to check for cancer recurrence and changes in brain function. The study will also compare the genetic makeup of the brain tumor to the original cancer and the patient's normal genes.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older (19 in Nebraska)
  • Good overall health with a Karnofsky Performance Score of 70 or higher
  • Classified as RPA class I or II
  • Have a known or suspected primary solid cancer with up to four brain tumors, each up to 4 cm in size, with surgery planned for one or two tumors
  • Adequate platelet count (100,000/mm3 or higher), transfusion allowed
  • Lab values suitable for surgery, transfusion allowed to meet goals
  • Women of childbearing potential must have a negative pregnancy test within 7 days before starting the study
  • INR of 1.3 or lower
  • Expected survival time of 3 months or more, as determined by the patient's primary oncologist
  • Willing and able to consent to and follow the study protocol

Exclusion Criteria

  • Previous treatment to the area planned for surgery (surgery or radiation)
  • Previous whole brain radiation therapy
  • Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer
  • Cancer spread to the membranes covering the brain and spinal cord (leptomeningeal disease)
  • Neurodegenerative disorders like dementia
  • Tumor larger than 4 cm
  • Classified as RPA class III
  • Unable or unwilling to follow the study requirements
  • Any significant medical or psychiatric condition that may interfere with the study or the ability to give informed consent
  • Participation in other therapeutic clinical trials
  • Severe heart, lung, or other systemic diseases, including:
    • Heart failure worse than Grade 2 within 6 months before the study, unless well controlled with medication
    • Uncontrolled or significant heart or lung disease
  • Any other disease that may affect compliance or increase risk of treatment complications
  • Bleeding disorders or need for blood thinners that cannot be stopped for surgery
  • Inability to have MRI scans

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