Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    75
  • sponsor
    Wake Forest University Health Sciences
Updated on 31 July 2021
Investigator
Karen Craver
Primary Contact
Randolph Hospital (0.0 mi away) Contact
+130 other location
ct scan
cancer
total bilirubin
absolute neutrophil count
potassium
MRI
chemoradiotherapy
neutrophil count
blood transfusion
complete resection
temozolomide
gliosarcoma
supratentorial glioblastoma multiforme
gross total resection
blood urea nitrogen
memory loss
tumor treating fields therapy
supratentorial glioblastoma

Summary

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

Description

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).

Details
Condition Glioblastoma Multiforme, Cognitive Impairment, Cognitive Dysfunction, Chemoradiation, Cognitive Decline, Chemoradiotherapy, Cognitive Impairments, Mental Deterioration, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, glioblastoma, neurocognitive disturbance, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications, Radiotherapy; Complications
Treatment ramipril
Clinical Study IdentifierNCT03475186
SponsorWake Forest University Health Sciences
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

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 35 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. 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
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
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