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Testing Ramipril to Prevent Memory Loss in People with Glioblastoma


Active: No
Cancer Type: Brain & Spinal Cord Tumor NCT ID: NCT03475186
Trial Phases: Protocol IDs: WF-1801 (primary)
WF-1801
WF-1801
NCI-2018-01807
Eligibility: 18 Years and older, Male and Female Study Type: Supportive care
Study Sponsor: Wake Forest NCORP Research Base
NCI Full Details: http://clinicaltrials.gov/show/NCT03475186

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. Patients also undergo collection of blood during screening and magnetic resonance imaging (MRI) or computed tomography (CT) scan throughout the trial.

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.