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

NCT00634322 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-09-15

Study results available
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Summary

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

Conditions

Interventions

DRUG

glucarpidase

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

DRUG

leucovorin

IV or po given every 6 hours

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • BTG International Inc.

    lead OTHER

Principal Investigators

  • Pete Anderson, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634322 on ClinicalTrials.gov