NTS-WBRT in Brain Metastases

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05013892
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Helen A Shih, MD, MS, MPH
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

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

Radiation

Drug: - Memantine

Capsule, taken orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

Helen A Shih, MD,MS,MPH

[email protected]

617-724-9627

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