NCT04217694CompletedEarly phase 1
Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 23 Dec 2019
- Start date
- Feb 2020
- Primary completion date
- Sept 2022
- Lead sponsor
- Mayo Clinic
- Diseases
- Childhood cancers
- NCT number
- NCT04217694
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 18
- From Feb 2020 to the primary completion date, Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior intracranial radiation
- 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
Other illness
- Any contraindication or allergy to memantine
- Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months
- 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
Other
- Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors
- Note: A patient with grade IV tumors of other histology can participate in the study if they meet all other criteria
- Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine)
- Note: occasional use as a sleep aid or as needed for anxiety or nausea is allowed
Who the study is looking for
- Receiving intracranial radiation for a primary central nervous system (CNS) malignancy
- Histological or radiologic confirmation of intracranial disease
- Able to use the computer for CogState assessment battery
- Normal serum creatinine per institutional normal limits (obtained =\< 35 days prior to study entry)
- 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)
- Aspartate transaminase (AST) AND alanine transaminase (ALT) =\< 2.5 x ULN
- Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.