A Phase IB Study of Proton Radiation to the Brain and Spinal Cord for Patients with Leptomeningeal Metastases

Full Title

A Phase IB Study with Dose Expansion Cohort of Proton Craniospinal Irradiation for Leptomeningeal Metastases from Solid Tumors

Purpose

The purpose of this study is to assess proton radiation therapy in patients with cancer that has spread to the space containing the brain, spinal cord, and cerebrospinal fluid (“leptomeningeal metastases”). Usually, leptomeningeal metastases are treated with standard high-energy x-ray radiation delivered only to the areas where cancer cells are causing symptoms, or where there is a tumor. But with the standard approach, cancer cells can move to untreated areas and clump together, causing headaches, nausea, vomiting, back pain, and weakness. Patients in this study will receive proton radiation therapy to the entire space where leptomeningeal cancer cells can travel (the space containing the brain, spinal cord, and cerebrospinal fluid), instead of only to areas where cancer cells are causing symptoms.

Standard radiation therapy uses high-energy x-rays to send radiation through the body to a tumor. But proton beam therapy uses charged particles (protons) instead of x-rays and, unlike x-rays, protons can be controlled to travel a certain distance within the body and then stop. So proton radiation may be less likely to cause side effects while treating areas around the brain and spinal cord.

Patients in this study will need to travel to a facility in Somerset, New Jersey for proton therapy.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a solid tumor with leptomeningeal metastases.
  • This study is for patients age 10 and older.

For more information about this study and to inquire about eligibility, please contact Dr. T. Jonathan Yang at 212-639-8157.

Protocol

18-205

Phase

I

Investigator