High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Phase 2TerminatedNCT00634322

BTG International Inc.7 enrolled

Overview

The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteosarcoma

Interventions

glucarpidaseDRUG

IV dose based on weight, two doses given for 5 minutes, 24 hours apart

leucovorinDRUG

IV or po given every 6 hours

Eligibility

Sex: ALLMin age: 8 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * osteosarcoma * eligible to receive 2 sequential cycles of HDMTX-LV Exclusion Criteria: * prior administration of glucarpidase * progression of disease while on previous MTX treatment

Outcomes

Primary Outcomes

Patients Progressing to Next Chemotherapy Cycle

Time frame: 1 week after intervention

Data from ClinicalTrials.gov

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