Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
Massachusetts General Hospital
Summary
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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 understan…
Interventions
- RadiationNTS-WBRT (normal tissue sparing whole brain radiation therapy)
Radiation
- DrugMemantine
Capsule, taken orally
Location
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts