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A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
 
Region Sponsors
California - Southern
NRG Oncology
 
Acronym KP IRB No.
10815
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Cognitive Impairment; Metastatic Malignant Neoplasm in the Brain; Solid Neoplasm
 
Purpose
This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Brain metastases outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to Step 1 registration. An allowed exception, regarding ability to image brain metastases, would be that patients who had undergone radiosurgery or surgical resection and are planning adjuvant WBRT do not have to have visible disease but do need a pre-surgery MRI or computed tomography (CT) scan demonstrating brain metastases. However, the brain metastases could not have been within 5 mm of either hippocampus
  • Patients must have a gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) axial MRI scan with standard axial and coronal gadolinium contrast-enhanced T1-weighted sequence and axial T2/FLAIR sequence acquisitions. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm. The associated coronal and sagittal contrast-enhanced T1 sequences can be up to 2.5 mm in slice thickness. This MRI must be obtained =< 21 days prior to step 1 registration. The vendor specific MRI protocols are available for download from the Alzheimer's Disease Neuroimaging Initiative (ADNI)
  • Patients must provide study-specific informed consent prior to registration
 
Exclusion Criteria
  • Prior external beam radiation therapy to the brain or whole brain radiation therapy
  • Planned cytotoxic chemotherapy during the WBRT only. Patients may have had prior chemotherapy
  • Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
  • Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to memantine (memantine hydrochloride)
  • Current alcohol or drug abuse (may exacerbate lethargy/dizziness with memantine)
  • Intractable seizures while on adequate anticonvulsant therapy—more than 1 seizure per month for the past 2 months
  • Patients with definitive leptomeningeal metastases
  • Patients with brain metastases from primary germ cell tumors, small cell carcinoma, unknown primary, or lymphoma
  • Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies
  • Contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
  • Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan

 
Keywords and/or Specific Medical Conditions
  • Anti-Dyskinesia Agents
  • Neoplasms
  • Antiparkinson Agents
  • Neoplasms by Site
  • Brain Diseases
  • Neoplasms, Second Primary
  • Central Nervous System Agents
  • Nervous System Diseases
  • Central Nervous System Diseases
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neurotransmitter Agents
  • Cognition Disorders
  • Pharmacologic Actions
  • Delirium, Dementia, Amnestic, Cognitive Disorders
  • Physiological Effects of Drugs
  • Dopamine Agents
  • Therapeutic Uses
  • Excitatory Amino Acid Agents
  • Brain Neoplasms
  • Excitatory Amino Acid Antagonists
  • Oncology (Adult)
  • Mental Disorders
  • Radiology
  • Molecular Mechanisms of Pharmacological Action
 
KP Clinical Facility
  • Los Angeles (Sunset)
 
Clinical Area
  • Oncology (Adult)
  • Radiology


Principal Investigator:
Michael Girvigian, MD
Contact Information:
- Kaiser Permanente Clinical Trials
-844-294-4114
-clinical.trials@kp.org
-Southern California


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