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Testing Ramipril to Prevent Memory Loss in People with Glioblastoma

Cancer Type
Brain & Spinal Cord Tumor
Trial Phase
18 Years and older, Male and Female
Study Type
Supportive care
Protocol IDs
WF-1801 (primary)
Study Sponsor
Wake Forest NCORP Research Base


This phase II trial studies how well ramipril works in preventing cognitive decline in patients with glioblastoma or gliosarcoma who are undergoing brain radiation therapy and chemotherapy with temozolomide. Adding ramipril to standard of care treatment may help to lower the chance of memory loss.


I. To assess the retention rate of patients at 10 weeks of ramipril treatment (6 weeks during radiation therapy [RT] and 4 weeks post RT) to determine whether or not we should proceed to a subsequent randomized study.
II. To estimate the effect of 10 weeks of ramipril on neurocognitive function in patients with glioblastoma (GBM) receiving chemoradiotherapy.

I. To estimate the time to neurocognitive decline with GBM receiving chemoradiotherapy and ramipril.
II. To estimate the effect of treatment with ramipril on and variability of specific non-memory cognitive functions including attention, executive function, visuo-motor skills, working memory, a screening measure of global cognitive function, mood, quality of life, fatigue and sleep disturbance.
III. To collect preliminary data on the presence of apolipoprotein epsilon (ApoE) isoform 4 serum (peripheral blood lymphocyte) test positivity as measured by quantitative polymerase chain reaction (PCR).
IV. To estimate neurocognitive function in surviving patients at the 4 month post RT endpoint.
V. To estimate response as reported by treating physician assessments.

I. To explore any subgroup differences for all secondary objectives measured at the post-RT 4 month visit by whether the patient received Optune (also known as Tumor-Treating Fields or TTFields) as part of their standard treatment following RT.

Beginning with standard of care RT and chemotherapy with temozolomide, patients receive ramipril orally (PO) once daily (QD) for 22 weeks (4 months post RT) in the absence of disease progression or unacceptable toxicity. After 1 month post RT, use of the Optune device may be used at the discretion of the treating physicians as per standard of care guidelines, timing and training. Patients also undergo collection of blood during screening and magnetic resonance imaging (MRI) or computed tomography (CT) scan throughout the trial.


  1. 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
  2. The tumor must have a supratentorial component
  3. History/physical examination within 14 days prior to enrollment
  4. The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment
  5. Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for 6 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-Patient-Reported Outcome (PRO) assessment
  6. Study drug (ramipril) must be given >= 21 days and =< 42 days after surgery
  7. 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
  8. Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
  9. Age >= 18
  10. Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to enrollment)
  11. Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to enrollment)
  12. 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)
  13. Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to enrollment
  14. Creatinine =< 1.7 mg/dl within 14 days prior to enrollment
  15. Total bilirubin =< 2.0 mg/dl within 14 days prior to enrollment
  16. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to enrollment
  17. Patient must provide study specific informed consent prior to study entry
  18. 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
  19. Patient must be able to complete neurocognitive tests in the English language as they are not validated in other languages at this time
  20. Women of childbearing potential and male participants must practice adequate contraception
  21. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment
  22. Local site must be able to follow the standard GBM radiation treatment dosimetry plan
  23. 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
  24. 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

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342

Atlanta Gynecologic Oncology

980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033

Georgia Gynecologic Oncology

980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342

Northside Hospital Cancer Institute - Forsyth

1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041

University Gynecologic Oncology

960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.