Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma
NCT03960177 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-01-07
Summary
This early phase I trial studies how well glucarpidase works in reducing toxicity in patients with osteosarcoma receiving high dose methotrexate treatment. Glucarpidase may reduce the levels of methotrexate in patients' blood and lead to shorter hospitalizations and a reduction in toxicities.
Conditions
Interventions
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- DRUG
-
Glucarpidase
Given IV
Sponsors & Collaborators
-
BTG International Inc.
collaborator OTHER -
Oregon Health and Science University
collaborator OTHER -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Christopher Ryan · OHSU Knight Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-27
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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