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

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00634322
First Posted: March 13, 2008
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
BTG International Inc.
March 6, 2008
March 13, 2008
November 30, 2012
September 15, 2014
September 15, 2014
October 2008
March 2009   (Final data collection date for primary outcome measure)
Patients Progressing to Next Chemotherapy Cycle [ Time Frame: 1 week after intervention ]
successful advancement to the next cycle of chemotherapy at scheduled time [ Time Frame: one week ]
Complete list of historical versions of study NCT00634322 on ClinicalTrials.gov Archive Site
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High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Osteosarcoma
  • Drug: glucarpidase
    IV dose based on weight, two doses given for 5 minutes, 24 hours apart
    Other Name: Voraxaze, caboxypeptidase G2, CPG2
  • Drug: leucovorin
    IV or po given every 6 hours
    Other Name: LV
  • Experimental: A
    HDMTX-LV with glucarpidase
    Intervention: Drug: glucarpidase
  • Active Comparator: B
    HDMTX-LV with placebo
    Intervention: Drug: leucovorin
  • Experimental: C
    compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment
    Intervention: Drug: glucarpidase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
April 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00634322
PR001-CLN-pro012
MDACC #2006-0246
No
Not Provided
Not Provided
BTG International Inc.
BTG International Inc.
M.D. Anderson Cancer Center
Principal Investigator: Pete Anderson, MD, PhD M.D. Anderson Cancer Center
BTG International Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP