What this study is
This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (VMAT), works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo CSF sample collection
- Computed Tomography
Intervention · PROCEDURE
Undergo PET/CT and/or CT
- Electronic Health Record Review
Intervention · OTHER
- Lumbar Puncture
Intervention · PROCEDURE
Undergo lumbar puncture
- Magnetic Resonance Imaging
Intervention · PROCEDURE
Undergo MRI
- Positron Emission Tomography
Intervention · PROCEDURE
Undergo PET/CT
- Proton Beam Craniospinal Irradiation
Intervention · RADIATION
Undergo proton CSI
- Survey Administration
Intervention · OTHER
- Volume Modulated Arc Therapy
Intervention · RADIATION
Undergo photon VMAT CSI
- Hippocampal-Avoidance Craniospinal Irradiation
Intervention · PROCEDURE
Undergo HA
Both Electronic Health Record Review and Survey Administration
Ancillary studies
Study details
- Official title
- A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
- Sponsor
- University of Washington
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8 · Metastatic Breast Carcinoma · Metastatic Lung Non-Small Cell Carcinoma · Metastatic Malignant Neoplasm in the Leptomeninges · Stage IV Lung Cancer AJCC v8
- Enrolling
- 22 people
- Starts
- 2025-03-03
- Est. completion
- 2028-07-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology
- Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
- Patients ≥ 18 years old
- Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2
- The patient is able to provide informed consent
- Hemoglobin > 8 g/dL
- Absolute neutrophil count > 1,000/mm
- Platelet count > 100,000/mm
- Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history [≥ 60 years old, or with no menses for > 1 year without an alternative medical cause], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT)
- Patients with reproductive potential must agree to practice two highly effective contraceptive methods
You can't join if
- Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- Patients with extensive systemic disease and without reasonable systemic treatment options
- Patients who are unable to undergo MRI brain and spine with gadolinium contrast
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
- Gross ventricular disease
- Brain metastases within 5 mm of the hippocampal contours not previously treated
- Pregnant or lactating women
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openUniversity of California San Francisco
San Francisco, California, United States
- Steve Braunstein · Principal investigator
Not yet recruitingLaura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
- Jonathan Yang · Principal investigator
RecruitingFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
- Lia M. Halasz · Contact206-897-2121lhalasz@uw.edu
- Lia M. Halasz · Principal investigator
Recruiting
Study team
Sponsor
University of Washington
Study ID RG1124476
Principal investigator
Lia M. Halasz
Fred Hutch/University of Washington Cancer Consortium
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.