Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 21, 2018
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).
Gender
ALL
Eligibility criteria
- 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).
- • Recurrent or multifocal malignant gliomas
- • Metastases detected below the tentorium or beyond the cranial vault
- • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
- • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
- * Severe active co-morbidity, defined as follows:
- • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
- • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment.
- • Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- • Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
- • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- • Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study unless they involve standard of care or over the counter therapies or do not involve a drug therapy.
- • Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study.
- • Patients with impaired decision-making capacity; this exclusion is necessary because such patients may not be able to adequately give informed consent.
- • Pregnant or lactating women, due to possible adverse effect on the developing fetus or infant due to study drug.
- * For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following exclusion criteria also apply:
- • Optune® is not permitted in patients who have an active implanted medical device, skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmatic shunts.
- • Optune® is not permitted in patients who are known to be sensitive to conductive hydrogels. Examples of conductive hydrogels are gels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
- • Patients being treated with Memantine, Donepezil, and/or medications prescribed to enhance cognition.
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Flint, Michigan, United States
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'Aiea, Hawaii, United States
Detroit Lakes, Minnesota, United States
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Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Marrero, Louisiana, United States
Fargo, North Dakota, United States
Chadds Ford, Pennsylvania, United States
Fort Myers, Florida, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Colorado Springs, Colorado, United States
Burnsville, Minnesota, United States
Greensboro, North Carolina, United States
Duluth, Georgia, United States
Snellville, Georgia, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
'Aiea, Hawaii, United States
'Ewa Beach, Hawaii, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Thief River Falls, Minnesota, United States
Clemmons, North Carolina, United States
Dublin, Ohio, United States
Tamuning, , Guam
Wilkesboro, North Carolina, United States
Hilo, Hawaii, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Columbus, Colorado, United States
'Aiea, Hawaii, United States
Nampa, Idaho, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Oshtemo, Michigan, United States
Grand Island, Nebraska, United States
Asheboro, North Carolina, United States
Greensboro, North Carolina, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Hazleton, Pennsylvania, United States
Bremerton, Washington, United States
Antigo, Wisconsin, United States
Irvine, California, United States
Sacramento, California, United States
Sacramento, California, United States
Atlanta, Georgia, United States
Patients applied
Trial Officials
Michael D Chan, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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