RECRUITING

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.

Official Title

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

Quick Facts

Study Start:2020-11-06

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04222062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older (Nebraska is 19 years or older) 2. Karnofsky Performance Score ≥ 70 3. RPA class I or II 4. Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for one or two tumors. 5. Adequate platelet count (≥ 100,000/mm3), transfusion permitted 6. Laboratory values adequate for patient to undergo surgery, including: (transfusion permitted to reach goals) 7. Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study 8. INR ≤ 1.3 9. Estimated survival time of ≥ 3 months as determined by the patient's primary oncologist. 10. The subject is willing and able to consent to and abide by the protocol.	1. Prior treatment to the area of planned resection (surgery, radiation). 2. Prior whole brain radiation therapy. 3. Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer. 4. Leptomeningeal disease 5. Neurodegenerative disorder (e.g. dementia). 6. Tumor size \> 4 cm. 7. RPA class III 8. Inability or unwillingness to co-operate with the requirements of the protocol 9. Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent. 10. Participation in other therapeutic clinical trials 11. Severe pulmonary, cardiac or other systemic disease, specifically: 1. New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication 2. Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia, clinically significant pulmonary disease 12. Subjects who have any other disease, either metabolic or psychological, which as per the Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications. 13. The subject has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including NSAIDs (non-steroidal anti-inflammatory drugs), at the time of scheduled resection that cannot be stopped for surgery. 14. Inability to obtain MRI studies.

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older (Nebraska is 19 years or older)
2. Karnofsky Performance Score ≥ 70
3. RPA class I or II
4. Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for one or two tumors.
5. Adequate platelet count (≥ 100,000/mm3), transfusion permitted
6. Laboratory values adequate for patient to undergo surgery, including: (transfusion permitted to reach goals)
7. Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study
8. INR ≤ 1.3
9. Estimated survival time of ≥ 3 months as determined by the patient's primary oncologist.
10. The subject is willing and able to consent to and abide by the protocol.

1. Prior treatment to the area of planned resection (surgery, radiation).
2. Prior whole brain radiation therapy.
3. Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer.
4. Leptomeningeal disease
5. Neurodegenerative disorder (e.g. dementia).
6. Tumor size \> 4 cm.
7. RPA class III
8. Inability or unwillingness to co-operate with the requirements of the protocol
9. Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent.
10. Participation in other therapeutic clinical trials
11. Severe pulmonary, cardiac or other systemic disease, specifically:
1. New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
2. Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia, clinically significant pulmonary disease
12. Subjects who have any other disease, either metabolic or psychological, which as per the Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complications.
13. The subject has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including NSAIDs (non-steroidal anti-inflammatory drugs), at the time of scheduled resection that cannot be stopped for surgery.
14. Inability to obtain MRI studies.

Contacts and Locations

Study Contact

Project Coordinator

CONTACT

402-559-0963

IITOffice@unmc.edu

Taylor A Johnson, BS, MA

CONTACT

402-559-0963

taylora.johnson@unmc.edu

Principal Investigator

Michele Aizenberg, MD

PRINCIPAL_INVESTIGATOR

University of Nebraska

Study Locations (Sites)

Henry Ford

Detroit, Michigan, 48202

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: University of Nebraska

Michele Aizenberg, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-06

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-11-06

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Brain Tumor - Metastatic