Clinical trial · Interventional
Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy. PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Neurotoxicity | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Memantine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Whole brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- WBRT+Memantine
- description
- Whole brain radiation therapy (WBRT) and memantine
- interventionNames
- Drug: Memantine
- Radiation: Whole brain radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- WBRT+Placebo
- description
- Whole brain radiation therapy (WBRT) and placebo
- interventionNames
- Other: Placebo
- Radiation: Whole brain radiation therapy
Primary outcomes (1)
- measure
- Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years * If the original histologic proof of malignancy is \> 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis) * Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days) * Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality * Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI * Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months) * Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans PATIENT CHARACTERISTICS: Inclusion * Karnofsky performance status 70-100% * Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min * Total bilirubin ≤ 2.5 mg/dL * Blood urea nitrogen (BUN) \< 20 mg/dL * Mini-mental status exam score ≥ 18 * Negative serum pregnancy test * Fertile patients must practice adequate contraception Exclusion * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Pregnant or lactating women * Prior allergic reaction to memantine hydrochloride * Current alcohol or drug abuse * Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months) PRIOR CONCURRENT THERAPY: Inclusion * At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection * No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT) Exclusion * Prior cranial radiotherapy * Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements * Chronic short-acting benzodiazepine use
References
Publications (1)
- DERIVEDBrown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16. PMID 23956241