Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy
City of Hope Medical Center
Summary
This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (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 and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. 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. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of photon-VMAT-CSI; assessed by median central nervous system progression free survival (CNS-PFS). SECONDARY OBJECTIVES: I. To estimate and assess central nervous system (CNS) response rate, response duration, and overall survival probability. II. To summarize and assess toxicities including: type, frequency, severity, attribution, time course and duration. III. To characterize and evaluate patient reported outcomes (PROs), including quality of life (QOL), measures: IIIa. QOL Questionnaire Brain 20 (European Organization for Research and Tre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * ≥ 18 years * Karnofsky performance status (KPS) ≥ 60 * Ability to read and understand English or Spanish for questionnaires, or ability to complete questionnaires using certified interpreter * Histologically confirmed breast cancer or non-small cell lung cancer * Leptomeningeal disease established either radiographically and/or CSF cytology * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 * Hemoglobin ≥ 8 g/…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and CSF sample collection
- RadiationCraniospinal Irradiation
Undergo photon-VMAT-CSI
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureLumbar Puncture
Undergo LP
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureOmmaya Reservoir Tap
Undergo Ommaya reservoir tap
- OtherQuestionnaire Administration
Locations (2)
- City of Hope Medical CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California