Malignant Central Nervous System NeoplasmEarly Phase 1NCT04217694
Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
A Early Phase 1 study testing Cogstate Assessment Battery, Memantine and Memantine Hydrochloride in people with Malignant Central Nervous System Neoplasm and Primary Central Nervous System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Malignant Central Nervous System Neoplasm, Primary Central Nervous System Neoplasm
- What is being tested?
- Cogstate Assessment Battery, Memantine and Memantine Hydrochloride
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 12 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
- Any prior intracranial radiation
- Any contraindication or allergy to memantine
- 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
Show all 9Show fewer
- Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT.
SECONDARY OBJECTIVE:
- To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.
EXPLORATORY OBJECTIVES:
- To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT.
II. 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.
III. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation.
IV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing.
- Disease-free (of primary tumor) and overall survival.
OUTLINE:
Patients 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.
After completion of study, patients are followed up periodically.
- Being tested
- Cogstate Assessment Battery, Memantine, Memantine Hydrochloride
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogstate Assessment BatteryBehavioural
Complete CogState testing
MemantineDrug
Given PO
Memantine HydrochlorideDrug
Also called Ebixia, Namenda
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Prevention (memantine, CogState) | Experimental | 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. Receives: Behavioral: Cogstate Assessment Battery; Drug: Memantine; Drug: Memantine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who attempt to take appropriate dose of memantine
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.
Measured: At 1 month post-radiation therapy (RT)
Secondary outcomes (1)
Percentage of patients who attempt to take appropriate dose of memantine
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.
Measured: At 3 and 6 months post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start17 Feb 2020
- Primary completion15 Sep 2022
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia N. Laack, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217694
- Sponsor's protocol ID
- MC1911
- Other IDs
- NCI-2019-08538, MC1911, 19-004245
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2019
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
- ClinicalTrials.gov ID
- NCT04217694
- Acronym / sponsor ID
- MC1911
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT.
SECONDARY OBJECTIVE:
- To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT.
EXPLORATORY OBJECTIVES:
- To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT.
II. 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.
III. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation.
IV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing.
- Disease-free (of primary tumor) and overall survival.
OUTLINE:
Patients 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.
After completion of study, patients are followed up periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (memantine, CogState) | Experimental | Behavioral: Cogstate Assessment Battery, Drug: Memantine, Drug: Memantine HydrochloridePatients 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors
- Any prior intracranial radiation
- Any contraindication or allergy to memantine
- Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine)
- Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogstate Assessment BatteryComplete CogState testing | Behavioural | Prevention (memantine, CogState) |
| MemantineGiven PO | Drug | Prevention (memantine, CogState) |
| Memantine HydrochlorideAlso: Ebixia, NamendaGiven PO | Drug | Prevention (memantine, CogState) |
Primary outcome
Percentage of patients who attempt to take appropriate dose of memantine
Time frame: At 1 month post-radiation therapy (RT)
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.
1 secondary outcome
Percentage of patients who attempt to take appropriate dose of memantine
Time frame: At 3 and 6 months post-RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia N. Laack, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cogstate Assessment Battery, Memantine and Memantine Hydrochloride in people with Malignant Central Nervous System Neoplasm and Primary Central Nervous System Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who attempt to take appropriate dose of memantine (time frame: At 1 month post-radiation therapy (RT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.