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

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.
 
ClinicalTrials.gov Identifier: NCT00634322
Recruitment Status : Terminated (Lack of enrollment)
First Posted : March 13, 2008
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
BTG International Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: glucarpidase Drug: leucovorin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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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 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


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

Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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Principal Investigator: Pete Anderson, MD, PhD M.D. Anderson Cancer Center
More Information
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Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00634322    
Other Study ID Numbers: PR001-CLN-pro012
MDACC #2006-0246
First Posted: March 13, 2008    Key Record Dates
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:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
 Leucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients