Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

Inclusion Criteria

• Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.
• The tumor must have a supratentorial component.
• History/physical examination within 14 days prior to enrollment.
• The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment
• Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for six weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 week [wk]) Neurocognitive-PRO assessment.
• Study drug (Ramipril) must be given >= 21 days and ≤ 42 days after surgery.
• All available brain magnetic resonance imaging (MRI) or computed tomography (CT) imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports.
• Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
• Absolute neutrophil count (ANC) >= 1, 500 cells/mm^3 (obtained within 14 days prior to enrollment)
• Platelets >= 100, 000 cells/mm^3 (obtained within 14 days prior to enrollment)
• Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (obtained within 14 days prior to enrollment)
• Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to enrollment
• Creatinine =< 1.7 mg/dl within 14 days prior to enrollment
• Total bilirubin =< 2.0 mg/dl within 14 days prior to enrollment
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to enrollment
• Patient must provide study specific informed consent prior to study entry
• Baseline potassium level <5.0 mEq/L. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility.

Patient must be able to complete neurocognitive tests in the English language

• Women of childbearing potential and male participants must practice adequate contraception
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment
• Local site must be follow the standard GBM radiation treatment dosimetry plan
• For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply:
• Patients must have only a supratentorial glioblastoma
• The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer
• Patients with prior malignancies if all treatment for that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.

Exclusion Criteria

• Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE) inhibitor
• Hypotension (< 110 mg Hg systolic) at the time of enrollment
• Renal insufficiency with creatinine clearance of < 40 ml/min (at time of enrollment)
• Solitary kidney or known renal artery stenosis
• Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study.
• Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible