A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
University of Washington
Summary
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.
Description
OUTLINE: Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients may also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients will undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and prin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 potentia…
Interventions
- ProcedureBiospecimen Collection
Undergo CSF sample collection
- ProcedureComputed Tomography
Undergo PET/CT and/or CT
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureLumbar Puncture
Undergo lumbar puncture
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET/CT
- RadiationProton Beam Craniospinal Irradiation
Locations (2)
- University of California San FranciscoSan Francisco, California
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington