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Sponsors and Collaborators: |
Protherics AAIPharma |
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Information provided by: | Protherics |
ClinicalTrials.gov Identifier: | NCT00481559 |
This protocol evaluates adjunctive treatment of patients receiving high-dose methotrexate (HDMTX; > or = to 1 g/m2) who are experiencing or at risk of MTX toxicity. Patients are considered at risk of MTX toxicity if they have impaired renal function, which can lead to a delay in MTX elimination, or have evidence of delayed elimination based on MTX levels.
Condition | Intervention |
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Neoplasms |
Drug: Voraxaze (glucarpidase) |
Study Type: | 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 |
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 prior to FDA marketing approval and to continue development through to approval, 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 312.7) 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 AAIPharma central call center (1-866-918-1731) to verify patient eligibility and 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.
Genders Eligible for Study: | Both |
Inclusion Criteria:
A. Patients with osteosarcoma:
B. All other patients:
Exclusion Criteria:
Responsible Party: | Protherics ( Suzanne Kincaid ) |
Study ID Numbers: | PR001-CLN-pro016 |
Study First Received: | May 30, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00481559 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Voraxaze glucarpidase carboxypeptidase cancer lymphoma leukemia |
osteosarcoma methotrexate delayed elimination renal insufficiency toxicity |
Folic Acid Antimetabolites Leukemia Renal Insufficiency Immunologic Factors Methotrexate |
Osteogenic Sarcoma Osteosarcoma Antirheumatic Agents Folic Acid Antagonists Immunosuppressive Agents Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Methotrexate Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |