Status:
COMPLETED
A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
Lead Sponsor:
Saint John's Cancer Institute
Conditions:
Newly Diagnosed High Grade Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before stan...
Detailed Description
Patients having a clinically planned surgical procedure (biopsy or cytoreduction) for a suspected diagnosis of high grade glioma will be approached for participation in this study. Tumor tissue obtain...
Eligibility Criteria
Inclusion
- Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
- Participant has the willingness to comply with all study procedures and availability for the duration of the study.
- Participant is being evaluated for a potential, or known, diagnosis of high grade glioma.
- Participant is a candidate for brain surgery or has undergone prior surgery and has not received any additional treatment for high grade glioma.
- Participant is male or female, ≥ 18 years of age.
- Participant has a Karnofsky Performance Status (KPS) ≥ 60%:
Exclusion
- Participant has received prior anti-cancer treatment for high grade glioma.
- Participant has a diagnosis of immunodeficiency or active autoimmune disease.
- Participant is receiving chronic systemic steroid therapy in dosing exceeding 8 mg daily of dexamethasone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Note: This is assessed after surgery, prior to starting drug treatment.
- Participant has received a live vaccine within 28 days prior to the first dose of study agent. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, and intranasal influenza vaccines (e.g., FluMist®).
- Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
- Participant is a female of childbearing potential who is pregnant or nursing.
- Participant has a history of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months.
- Participant has a history of intestinal perforations, fistula, hemorrhages, and/or hemoptysis ≤ 6 months prior to first study treatment.
- Participant has active gastrointestinal bleeding.
- Participant has uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg).
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03425292
Start Date
March 1 2018
End Date
October 27 2023
Last Update
November 8 2023
Active Locations (1)
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1
Saint John's Cancer Institute
Santa Monica, California, United States, 90404