Study ID: NRG CC001
This trial is testing the drug memantine combined with whole brain radiation therapy—with or without avoiding the hippocampus—for patients with cancer that has spread to the brain.
Whole brain radiation therapy (WBRT) is the primary treatment option for patients with multiple brain metastases (more than one lesion on the brain) due to cancer that has spread to the brain from another part of the body.
Unfortunately, WBRT can also contribute to cognitive decline, such as loss of memory and learning, in the remaining months of the patient’s life. The purpose of this trial is to determine whether the drug memantine hydrochloride can help preserve cognitive function, which in turn improves quality of life for patients and families. The drug will be tested in patients who receive hippocampal-avoidance WBRT (HA-WBRT) as well as in those who receive standard WBRT.
The main testing requirements for participation include a contrast-enhanced MRI and additional SPGR (spoiled gradient), MP-RAGE (magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFO) axial MRI scan.
Randomized phase III trial of memantine and whole-brain radiotherapy with or without hippocampal avoidance in patients with brain metastases
Brain metastatses must be visible via a contrast-enhanced MRI; 5-mm margin around either hippocampus. MRI must be performed < 21 days prior to Step 1 registration. See protocol for specifics of testing. Prior to Step 2: Baseline neurocognitive testing; pathologically proven diagnosis of solid tumor malignancy within five years.
Intervention/treatment: Experimental: Arm I (memantine hydrochloride, WBRT) patients receive memantine PO BID for 24 weeks. Patients undergo WBRT daily over approximately two weeks (10 fractions).
- Must have brain metastases as shown on contrast-enhanced MRI
- Must have 5mm-margin (space) around either hippocampus
- Must agree to take memantine hydrochloride by mouth, two times a day, for 24 weeks
- Must agree to undergo WBRT every day for approximately two weeks
Additional criteria may apply.