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Testing Ramipril to Prevent Memory Loss in People with Glioblastoma

Status
Active
Cancer Type
Brain & Spinal Cord Tumor
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT03475186
Protocol IDs
WF-1801 (primary)
WF-1801
WF-1801
NCI-2018-01807
Study Sponsor
Wake Forest NCORP Research Base

Summary

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.

Objectives

PRIMARY OBJECTIVES:
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.

SECONDARY OBJECTIVES:
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.

EXPLORATORY OBJECTIVE:
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.

OUTLINE:
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.

Eligibility

  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 =< 35 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. Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to enrollment)
  10. Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to enrollment)
  11. 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)
  12. Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to enrollment
  13. Creatinine =< 1.7 mg/dl within 14 days prior to enrollment
  14. Total bilirubin =< 2.0 mg/dl within 14 days prior to enrollment
  15. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to enrollment
  16. Patient must provide study specific informed consent prior to study entry
  17. 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
  18. Patient must be able to complete neurocognitive tests in the English language as they are not validated in other languages at this time
  19. Women of childbearing potential and male participants must practice adequate contraception
  20. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment
  21. Local site must be able to follow the standard GBM radiation treatment dosimetry plan
  22. 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
  23. 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
770-777-1315
www.atlantacancercare.com

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming


1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Atlanta Cancer Care - Tower


5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Atlanta Gynecologic Oncology


980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342
404-303-3355
www.geraldfeuer.com

Georgia Cancer Specialists - Athens


125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Georgia Cancer Specialists - Canton


228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Georgia Cancer Specialists - CenterPointe


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

Georgia Cancer Specialists - Kennestone


790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Georgia Cancer Specialists - Stemmer


2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Georgia Gynecologic Oncology


980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342
404-303-3355
www.ggo-atl.com/

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Northside Hospital Cancer Institute - Forsyth


1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

University Gynecologic Oncology


960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
404-303-3355
www.ugynonc.com

**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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.