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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.
  Purpose
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

Condition Intervention Phase
Osteosarcoma Drug: glucarpidase Drug: leucovorin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized, Blinded, Placebo-Controlled Trial of High Dose Methotrexate With Leucovorin Rescue (HDMTX-LV) With or Without Glucarpidase in Osteosarcoma

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Patients Progressing to Next Chemotherapy Cycle [ Time Frame: 1 week after intervention ]

Enrollment: 7
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
HDMTX-LV with glucarpidase
Drug: glucarpidase
IV dose based on weight, two doses given for 5 minutes, 24 hours apart
Other Name: Voraxaze, caboxypeptidase G2, CPG2
Active Comparator: B
HDMTX-LV with placebo
Drug: leucovorin
IV or po given every 6 hours
Other Name: 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 Name: Voraxaze, caboxypeptidase G2, CPG2

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634322


Sponsors and Collaborators
BTG International Inc.
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Pete Anderson, MD, PhD M.D. Anderson Cancer Center
  More Information

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00634322     History of Changes
Other Study ID Numbers: PR001-CLN-pro012
MDACC #2006-0246
First Submitted: March 6, 2008
First Posted: March 13, 2008
Results First Submitted: November 30, 2012
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by BTG International Inc.:
osteosarcoma
high dose methotrexate
leucovorin

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors