Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity

This treatment has been approved for sale to the public.
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00481559
First received: May 30, 2007
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function


Condition Intervention
Neoplasms
Drug: Voraxaze (glucarpidase)

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Intervention Details:
    Drug: Voraxaze (glucarpidase)
    50 Units/kg in a bolus intravenous injection over 5 minutes
    Other Names:
    • carboxypeptidase
    • CPG2
    • CPDG2
Detailed Description:

This treatment protocol will be available on a cost recovery basis to IRB-approved Investigators treating an eligible patient at any site in the US. In order to continue to make Voraxaze™ available following FDA approval and prior to being commercially available. Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™ under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations (21 CFR 312.8) to charge for Voraxaze, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit).

Patient eligibility is based on MTX concentrations and laboratory values obtained per standard of care. Once an Investigator identifies a potential patient, he/she will contact the Voraxaze central call center (1-877-398-9829) to receive information regarding drug shipment. Eligible patients will have routine demographic, MTX, and Voraxaze therapy information collected.

Each patient will receive a single dose of Voraxaze 50 Units/kg in a bolus intravenous injection over 5 minutes. In addition to Voraxaze, patients will continue to receive standard of care treatment including leucovorin therapy, and supportive care such as hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female patients of any age who are experiencing delayed MTX clearance due to impaired renal function will be eligible to receive Voraxaze if the have toxic plasma MTX concentrations (>1 micromole per liter).

Exclusion Criteria:

  • Voraxaze is not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to MTX.
  • Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)

Patients intolerant to lactose in food (e.g., dairy products) can still receive Voraxaze.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481559

Sponsors and Collaborators
BTG International Inc.
CTI Clinical Trial and Consulting Services
Investigators
Study Chair: Paul Litka, MD BTG (contract)
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00481559     History of Changes
Other Study ID Numbers: PR001-CLN-pro016
Study First Received: May 30, 2007
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
Voraxaze
glucarpidase
carboxypeptidase
cancer
lymphoma
leukemia
osteosarcoma
methotrexate
delayed elimination
renal insufficiency
toxicity

Additional relevant MeSH terms:
Neoplasms
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on April 17, 2014