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Brain & Spine Tumors Trials

Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

Aims:The purpose of this Phase III study is to finally attain a clear answer to the long-standing question of which treatment route leads to the best clinical outcome for patients with newly diagnosed WHO grade II meningioma. Subjects will be randomly assigned into one of two groups: Group 1 will be observed following surgery and Group 2 will receive radiation therapy following surgery.
Principal Investigator: Bruce Brockstein, MD
NorthShore Project Number: EH18-270
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes

A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab versus Temozolomide in Patients with Newly Diagnosed Mgmt (Tumor O-6-Methylguanine Dna Methyltransferase) Unmethylated Glioblastoma
Aim: The purpose of the study is to find out whether adding ipilimumab and nivolumab to radiotherapy will significantly prolong progression free survival versus adding temozolomide to radiotherapy in patients with newly diagnosed glioblastoma without MGMT promoter methylation.
Principal Investigator: Bruce Brockstein, MD
NorthShore Project Number: EH20-366
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: on hold

A PHASE II STUDY OF CHECKPOINT BLOCKADE IMMUNOTHERAPY IN PATIENTS WITH SOMATICALLY HYPERMUTATED RECURRENT GLIOBLASTOMA    

Aim: Glioblastoma multiforme (GBM) is the most aggressive of the primary brain tumors. It remains uniformly lethal, and there are no treatments that extend survival once it recurs. The purpose of this study is to determine whether the combination of ipilimumab and nivolumab can lower the chance of recurrent glioblastoma with elevated mutational burden from growing or spreading after initial therapy failed. For this study, “high mutational burden” is defined as at least 20 mutations on the Foundation One CDx test.
Principal Investigator: Bruce Brockstein, MD
NorthShore Project Number: EH21-065
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes

PHASE II TRIAL of the IMMUNE CHECKPOINT INHIBITOR NIVOLUMAB in PATIENTS with SELECT RARE CNS CANCERS   

Aim: There are more than 130 identified primary tumors of Central Nervous System(CNS) and because these tumors are so rare there are insufficient proven therapies. Most of these neoplasms are surgically resected followed by treatment with radiotherapy. With few exceptions, there are no effective systemic regimens and even in chemotherapy sensitive disease, most patients with recurrence eventually have no remaining salvage treatments available.The purpose of this study is to determine whether nivolumab can shrink tumors that have returned in patients with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread throughout the body.
Principal Investigator: Janardan Khandekar, MD
NorthShore Project Number: EH21-004
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SSRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

Aim: The main goal of this study is to ascertain whether time to surgical bed failure is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS) in patients with resected brain metastasis. Secondary objectives include showing if there is better emotional wellbeing at 9 months in patients with resected brain metastasis undergoing FSRS compared to SSRS and learning whether there is improved overall survival in patients with resected brain metastases who undergo FSRS compared to patients who receive SSRS.
Principal Investigator: Bruce Brockstein, MD
NorthShore Project Number: EH21-169
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes

A Phase I study of safety and tolerability of acetazolamide with temozolomide in adults with newly diagnosed MGMT promotermethylated malignant glioma

Aim: This is a Phase I study that examines the rate of dose-limiting side effects in patients with malignant astrocytoma treated with combination acetazolamide (ACZ) and temozolomide (TMZ). Eligible patients must have histologically proven, newly diagnosed, O6-methylguanine-DNA methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and ionizing radiation).
Principal Investigator: Janardan Khandekar, MD
NorthShore Project Number: EH18-083
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes