Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT04217694
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in neurocognitive function (NCF)', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'Will be summarized and reported descriptively. This will be assessed using results from neurocognitive testing. Differences between scores from baseline and 12 months post-RT will be calculated, along with corresponding 90% confidence intervals. Change index (reliable change index \\[RCI\\]) will be calculated as well over this time period. A paired t-test or the Wilcoxon rank-sum test will be used as applicable. Additional analyses concerning change in NCF using additional subscales from the results of neurocognitive testing may be performed, but will be hypothesis generating and considered exploratory. These may include the use of other neurocognitive testing subscales using t-tests or the Wilcoxon rank-sum test, variations of RCI, and linear regression to assess the relationship of each subscale with changes in NCF.'}, {'measure': 'Change in NCF - CogState', 'timeFrame': 'Baseline up to 6 months post-RT', 'description': 'Determined by the CogState composite score. Will be summarized and compared to baseline values. Additional analyses concerning NCF at or between various time points may be performed, but will be hypothesis generating and considered exploratory. These may include comparisons of NCF between baseline and the end of RT, 3 months, and 12 months post-RT. Subscales of the results from the CogState may also be used for these analyses. CogState is a computerized cognitive test that will include the following battery of tests: International Shopping List Test (verbal learning and delayed recall), Detection (processing speed), Identification (attention), One Card Learning (visual memory), and One Back (working memory). Higher scores generally indicate greater NCF.'}, {'measure': 'Change in NCF - neuropsychological exam', 'timeFrame': 'Baseline up to 6 months post-RT', 'description': 'Determined by neuropsychological examination. Will be summarized and compared to baseline values. Additional analyses concerning change in NCF at or between various time points may be performed, but will be hypothesis generating and considered exploratory. These may include comparisons of NCF between baseline and the end of RT, 3 months, and 12 months post-RT .'}, {'measure': 'Change in quantitative volumetric brain imaging', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': 'Neuroquant Software will be used to analyze quantitative magnetic resonance imaging measurements of changes in hippocampal volume. Differences between measurements will be reported, along with corresponding 90% confidence intervals. A paired t-test or the Wilcoxon rank-sum test will be used as applicable. Additional analyses concerning hippocampal volume may be performed, but will be hypothesis generating and considered exploratory.'}, {'measure': 'Change in cognition', 'timeFrame': 'Baseline up to 12 months post-RT', 'description': "Cognitive changes detected by the CogState composite score will be correlated with results from formal neuropsychological testing using Pearson's r or Spearman's rank method, as applicable."}, {'measure': 'Disease-freedom from primary tumor', 'timeFrame': 'Up to 2 years', 'description': 'Will be analyzed using Kaplan-Meier.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 2 years', 'description': 'Will be analyzed using Kaplan-Meier.'}], 'primaryOutcomes': [{'measure': 'Percentage of patients who attempt to take appropriate dose of memantine', 'timeFrame': 'At 1 month post-radiation therapy (RT)', 'description': 'The rate of feasibility (the percentage of patients who attempt to take at least 80% percent of their prescribed dose) will be calculated, along with corresponding 90% confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who attempt to take appropriate dose of memantine', 'timeFrame': 'At 3 and 6 months post-RT', 'description': 'The rate of feasibility (the percentage of patients who attempt to take at least 80% percent of their prescribed dose) will be calculated, along with corresponding 90% confidence intervals.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Central Nervous System Neoplasm', 'Primary Central Nervous System Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This early phase I trial studies the feasibility of giving memantine for the reduction of cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors. Memantine may reduce the effects of radiation therapy on memory and thinking.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT.\n\nSECONDARY OBJECTIVE:\n\nI. To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT.\n\nII. To compare the change in NCF between baseline and the end of RT, 3,and 6 months after RT using both neuropsychological testing and the CogState exam.\n\nIII. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation.\n\nIV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing.\n\nV. Disease-free (of primary tumor) and overall survival.\n\nOUTLINE:\n\nPatients receive memantine orally (PO) BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.\n\nAfter completion of study, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving intracranial radiation for a primary central nervous system (CNS) malignancy\n* Histological or radiologic confirmation of intracranial disease\n* Able to use the computer for CogState assessment battery\n* Normal serum creatinine per institutional normal limits (obtained =\\< 35 days prior to study entry)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) OR direct bilirubin =\\< ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained =\\< 35 days prior to study entry)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) =\\< 2.5 x ULN\n* Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17\n* Negative pregnancy test done =\\< 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception\n\nExclusion Criteria:\n\n* Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors\n\n * Note: A patient with grade IV tumors of other histology can participate in the study if they meet all other criteria\n* Any prior intracranial radiation\n* Any contraindication or allergy to memantine\n* Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine)\n\n * Note: occasional use as a sleep aid or as needed for anxiety or nausea is allowed\n* Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT04217694', 'briefTitle': 'Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors', 'orgStudyIdInfo': {'id': 'MC1911'}, 'secondaryIdInfos': [{'id': 'NCI-2019-08538', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'MC1911', 'type': 'OTHER', 'domain': 'Mayo Clinic'}, {'id': '19-004245', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (memantine, CogState)', 'description': 'Patients receive memantine PO BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT.', 'interventionNames': ['Behavioral: Cogstate Assessment Battery', 'Drug: Memantine', 'Drug: Memantine Hydrochloride']}], 'interventions': [{'name': 'Cogstate Assessment Battery', 'type': 'BEHAVIORAL', 'description': 'Complete CogState testing', 'armGroupLabels': ['Prevention (memantine, CogState)']}, {'name': 'Memantine', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Prevention (memantine, CogState)']}, {'name': 'Memantine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Ebixia', 'Namenda'], 'description': 'Given PO', 'armGroupLabels': ['Prevention (memantine, CogState)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nadia N. Laack, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}