A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy
18 Years and older, Male and Female
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.
Treatment Sites in Georgia
1100 Johnson Ferry Road
Sandy Springs, GA 30342
404-256-4777 ext 9242www.gacancer.com
960 Johnson Ferry Road
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