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An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity

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Trial Information

An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity

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.

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

- Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)

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

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Paul Litka, MD

Investigator Role:

Study Chair

Investigator Affiliation:

BTG (contract)


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Neoplasms
  • Voraxaze
  • glucarpidase
  • carboxypeptidase
  • cancer
  • lymphoma
  • leukemia
  • osteosarcoma
  • methotrexate
  • delayed elimination
  • renal insufficiency
  • toxicity
  • Neoplasms