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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by:
Protherics
ClinicalTrials.gov Identifier:
NCT00634322
First received: March 6, 2008
Last updated: July 28, 2011
Last verified: July 2011

March 6, 2008
July 28, 2011
October 2008
March 2009   (final data collection date for primary outcome measure)
successful advancement to the next cycle of chemotherapy at scheduled time [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00634322 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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
8
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
Both
8 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00634322
PR001-CLN-pro012, MDACC #2006-0246
No
Peter M. Anderson, MD, PhD/Principal Investigator, M.D. Anderson Cancer Center
Protherics
M.D. Anderson Cancer Center
Principal Investigator: Pete Anderson, MD, PhD M.D. Anderson Cancer Center
Protherics
July 2011

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