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New treatment option for Brain Metastases
Official title Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique
ClinicalTrials.gov ID: NCT05045950
What this study is testing
What is Memantine -Twice Daily or Extended Release?
Memantine -Twice Daily or Extended Release is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for brain metastases.
Also referred to as Namenda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at diagnosis of brain metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2.
- Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the...
- Patients who have undergone prior systemic therapy are eligible.
- Life expectancy from extracranial disease greater than six months.
You likely can't join if
- Metastases from hematological malignancy, or central nervous system malignancy.
- Patients whose malignancy is being treated with curative intent.
- Leptomeningeal metastases.
- Contraindication to MRI imaging with contrast.
- Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.
- Stage IV-V chronic kidney disease or end-stage renal disease.
See the full eligibility criteria
- Age ≥18 years at diagnosis of brain metastases.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of \<2.
- Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically...
- Patients who have undergone prior systemic therapy are eligible.
- Life expectancy from extracranial disease greater than six months.
- Patients with measurable brain metastasis.
- Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS...
- If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.
- Creatinine clearance is ≥ 30 mL/min.
- Start of PRDR WBRT within two weeks following registration.
- Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).
- Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.
- Willing and able to give consent and to comply with treatment and follow-up schedule.
- Metastases from hematological malignancy, or central nervous system malignancy.
- Patients whose malignancy is being treated with curative intent.
- Leptomeningeal metastases.
- Contraindication to MRI imaging with contrast.
- Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.
- Stage IV-V chronic kidney disease or end-stage renal disease.
- Participants with a maximum tumor diameter exceeding 5 cm (if not resected).
- Prior cranial whole brain radiation therapy.
- Past medical history of dementia which is thought to be unrelated to the brain metastases.
- Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.
- Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and/or follow-up visits.
- Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.