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

September 9, 2014 updated by: BTG International Inc.

Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
HDMTX-LV with glucarpidase
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
Other Names:
  • Voraxaze, caboxypeptidase G2, CPG2
Active Comparator: B
HDMTX-LV with placebo
Drug: leucovorin
IV or po given every 6 hours
Other Names:
  • LV
Experimental: C
compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
Other Names:
  • Voraxaze, caboxypeptidase G2, CPG2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients Progressing to Next Chemotherapy Cycle
Time Frame: 1 week after intervention
1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTG International Inc.

Collaborators

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Pete Anderson, MD, PhD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR001-CLN-pro012
  • MDACC #2006-0246

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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