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ACE Inhibitor

Ramipril for Memory Loss in Glioblastoma Patients

Phase 2

Waitlist Available

Led By Michael D Chan, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Study drug (Ramipril) must be given >= 21 days and ≤ 42 days after surgery.

Must not have

Various prior treatment exclusions including chemotherapy, radiosensitizers, and radiotherapy to specific areas.

Patients planning to receive therapeutic antitumor agents in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 10 weeks, 22 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether Ramipril can help cancer patients undergoing chemoradiation treatment by reducing memory loss. Patients will take the drug throughout treatment and for four months after. Memory will be assessed using neurocognitive tests.

Who is the study for?

This trial is for adults with glioblastoma who are about to receive chemoradiation. They must have proper kidney, liver, and blood function, no prior use of ACE inhibitors or certain cancer treatments, and cannot be pregnant. Participants should not have other serious medical conditions that could interfere with the study.

What is being tested?

The trial tests if Ramipril can prevent memory loss in glioblastoma patients undergoing chemoradiation. Patients will take Ramipril starting from 21 to 42 days after surgery until four months post-treatment while their memory is monitored using neurocognitive tests.

What are the potential side effects?

Ramipril may cause a dry cough, dizziness due to low blood pressure, high potassium levels which can affect heart rhythm, kidney function changes, and swelling in parts of the body like lips or eyelids (angioedema).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of glioblastoma or gliosarcoma was confirmed through surgery, not just a needle biopsy.

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I will start the study drug between 3 to 6 weeks after my surgery.

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My tumor is located in the upper part of my brain.

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I can take care of myself and am up and about more than half of my waking hours.

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I can complete tests in English.

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I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had certain cancer treatments like chemotherapy or radiation to specific areas.

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I am not planning to receive extra cancer treatments besides standard radiation and temozolomide.

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My brain cancer has come back or is in multiple places.

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I have only one kidney or a narrowed kidney artery.

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My cancer has spread to the lower part of my brain or beyond.

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I am unable to make medical decisions for myself.

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My kidneys are not working well, with a creatinine clearance below 40 ml/min.

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I am not pregnant and willing to use contraception if of childbearing potential.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Neurocognitive Function at 10 weeks - Controlled Oral Word Association Test (COWA)

Change from Baseline Neurocognitive Function at 10 weeks - Hopkins Verbal Learning Test-Revised (HVLT-R)

Change from Baseline Neurocognitive Function at 10 weeks - Trail Making Test Part A and B (TMT A & B)

+2 more

Secondary study objectives

Determine Presence of Apolipoprotein Epsilon (ApoE)

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20)

Efficacy of neurocognitive function in surviving patients- COWA

+6 more

Side effects data

From 2009 Phase 4 trial • 252 Patients • NCT00391846

Cardiac Failure

Myocardial Infarction

Anaemia

Chronic Obstructive Pulmonary Disease

Syncope

Ventricular Tachycardia

Angina Pectoris

Artial Fibrillation

Dyspnoea

Hyperkalaemia

Pneumonia

Aortic Stenosis

Cerebral Infarction

Cerebrovascular Accident

Concussion

Confusional State

Diverticulitis

Duodenal Ulcer Haemorrhage

Dyspepsia

Endocarditis

Hepatic Failure

Intestinal Ischaemia

Multi-Organ Failure

Polymyalgia Rheumatica

Right Ventricular Failure

Spinal Fracture

Back Pain

Bladder Neoplasm

Blood Electrolytes Abnormal

Bradycardia

Muscular Weakness

Osteoarthritis

Angina Unstable

B-Cell Lymphoma

Bleeding Varicose Vein

Bronchitis

Carotid Artery Stenosis

Intervertebral Disc Compression

Pulmonary Odema

Respiratory Tract Infection Viral

Septic Shock

Peripheral Ischaemia

100%

80%

60%

40%

20%

Study treatment Arm

Guided by NT-proBNP

Not Guided by NT-proBNP

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RamiprilExperimental Treatment1 Intervention

Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ramipril

2005

Completed Phase 4

~70860

0 / 14Eligibility criteria met