Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy

Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation

Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment

Patients with extensive, uncontrolled extracranial systemic disease

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Craniospinal Irradiation
  • Electronic Health Record Review
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Ommaya Reservoir Tap
  • Questionnaire Administration
  • Volume Modulated Arc Therapy

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator