A Pilot Study of Glucarpidase in Adults Receiving High-Dose Methotrexate for Osteosarcoma

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Full Title

An Open-label, Multi-institutional Pilot Study to Assess the use of Glucarpidase in Adult Patients with Osteosarcoma Receiving High-dose Methotrexate

Purpose

Methotrexate is a standard chemotherapy drug given to people with osteosarcoma (bone cancer). Very high doses of methotrexate (HD-MTX) are given in the hospital, and patients remain in the hospital for monitoring after each dose. People over age 40 usually do not receive HD-MTX because the drug is thought to be poorly tolerated in older adults.

Glucarpidase is a medication currently used as a “rescue agent” to reverse some of the side effects occurring in people who receive HD-MTX. Researchers are doing this study to learn if giving glucarpidase 24 and 48 hours after HD-MTX treatment is a safe way to reduce methotrexate levels in the blood. This could reduce side effects and shorten hospital stays. Glucarpidase is given intravenously (by vein).

Eligibility

This study is for people age 25 and older who will receive HD-MTX to treat osteosarcoma.

For more information about this study, please contact the office of Dr. Katherine Thornton at 646-888-6952.

Protocol

21-173

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators