A Pilot Study of Voraxaze (Glucarpidase) in Patients with Central Nervous System Lymphoma

Full Title

A Pilot Study of Voraxaze (glucarpidase) in Patients with Central Nervous System Lymphoma

Purpose

The purpose of this study is to evaluate the effects of a drug called Voraxaze when routinely given in combination with methotrexate and rituximab, the standard treatment for central nervous system lymphoma (CNSL). Although methotrexate is very important for treating CNSL, it can sometimes cause serious side effects when methotrexate levels in the blood remain high for a long time. Voraxaze has been approved by the FDA to treat people who have experienced serious side effects due to high levels of methotrexate.

The researchers of this study hope to demonstrate that lower doses of Voraxaze can be given in patients routinely to reduce levels of methotrexate after treatment and to prevent side effects. This may result in shorter hospital stays. Voraxaze has already been studied in combination with rituximab and methotrexate and has been demonstrated to be safe. However, the most effective dose of Voraxaze (when given in combination with rituximab and methotrexate) is not yet known.

All three medications in this study are given in the hospital intravenously (by vein) over several days.

Eligibility

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

  • Patients must have primary or secondary CNSL, either newly diagnosed or recurrent.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Lauren Schaff at 212-610-0485.

Protocol

18-410

Phase

Pilot

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators