An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

About this Study

The purpose of this research is to evaluate multiple investigational treatments for either newly diagnosed or recurrent brain tumors to determine if any of these study treatments improve overall survival as compared to standard treatments.

Sponsor Protocol ID:GCAR-7213
IRB Number:2019-0171
Actively Enrolling
Phase 2
June 17, 2020
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria1. Age ≥ 18 years.

2. MRI within 21 days prior to randomization. 

3. Post-operative MRI within 96 hours of surgery 

4. Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the Investigator.

5. For women who are not postmenopausal (i.e.,

Exclusion Criteria1. Candidate for urgent palliative intervention for primary disease (e.g., impending herniation) as judged by the Investigator.

2. History of allergy or hypersensitivity to any of the study treatments or any of their excipients.

3. Serious, non-healing wound, ulcer, bone fracture, or abscess.

4. Uncontrolled or severe cardiac disease (e.g., history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the last 6 months prior to initiation of study treatment), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation), requirement for inotropic support or use of devices for cardiac conditions (e.g., pacemakers/defibrillators), or hypertension (participants with systolic blood pressure [BP] of > 160 mmHg or diastolic BP of > 100 mmHg despite optimal medical management are to be excluded).

5. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.

6. Known history of hepatitis B, human immunodeficiency virus (HIV), or active hepatitis C infection requiring treatment with antiviral therapy.  

7. History of bleeding diathesis (irrespective of severity).

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Bridgett Sessions
Phone Number: 601-984-1962
Principal Investigator:Anderson, Mark D, M.D.
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