NTS-WBRT in Brain Metastases

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Brain Metastases

Treatments: Drug: Memantine; Radiation: NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05013892

21-356

Details and patient eligibility

About

This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).

This research study involves:

• NTS-WBRT (normal tissue sparing whole brain radiation therapy)
• Memantine standard of care drug

Full description

This is a Phase 2 trial testing the safety and effectiveness of NTS-WBRT (normal tissue sparing whole brain radiation therapy) in treating brain metastases.

NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

It is expected that about 41 people will take part in this research study.

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
• Age ≥ 18
• Karnofsky Performance Status ≥ 70
• Prior stereotactic radiosurgery (SRS) permissible per physician discretion
• Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
• Prior partial brain radiation therapy permissible if target volume < 50% brain and per physician discretion
• Expectant > 6 months survival
• Ability to understand and the willingness to sign a written informed consent document.
• Fluency in English, able to complete questionnaires and neurocognitive testing
• Ability to undergo MRI with gadolinium examination
• Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
• Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
• Negative pregnancy test for premenopausal women

Exclusion criteria

• Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
• Prior whole brain radiation therapy
• Pre-existing or current use of memantine or other NMDA antagonists
• Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
• Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
• Concurrent participation in an investigational systemic therapy protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine

Experimental group

Description:

Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive: * NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks. * Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor

Treatment:

Radiation: NTS-WBRT (normal tissue sparing whole brain radiation therapy)

Drug: Memantine