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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

Further study details as provided by Protherics:

Primary Outcome Measures:
  • successful advancement to the next cycle of chemotherapy at scheduled time [ Time Frame: one week ] [ Designated as safety issue: No ]

Enrollment: 8
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

Ages Eligible for Study:   8 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634322

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

No publications provided

Responsible Party: Peter M. Anderson, MD, PhD/Principal Investigator, M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00634322     History of Changes
Other Study ID Numbers: PR001-CLN-pro012, MDACC #2006-0246
Study First Received: March 6, 2008
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Protherics:
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
Leucovorin
Levoleucovorin
Methotrexate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antidotes
Protective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 22, 2013