VORAXAZE SUMMARY
VORAXAZE (glucarpidase) is a carboxypeptidase produced by recombinant DNA technology in genetically modified Escherichia coli.
Indication
VORAXAZE (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.
Limitation of Use
VORAXAZE is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.
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NEWS HIGHLIGHTS
Clinical Trials Related to Voraxaze (Glucarpidase)
Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays? [Terminated]
Methotrexate is one of the most effective chemotherapy drugs in the treatment of
osteosarcoma and some other types of bone sarcoma which are treated the same way as
osteosarcoma. However, it frequently leads to sore mouth, tummy pain and increased risk of
developing infections.
The investigators try to save or "rescue" normal cells from the side effects of methotrexate
by giving a drug called folinic acid. Folinic acid is started 24 hours after methotrexate
and given regularly until methotrexate levels are really low and not dangerous to normal
cells anymore. Despite this rescue, side effects are still a problem and many patients are
not well enough to receive subsequent chemotherapy on time. Almost half of the planned
chemotherapy cycles are not given on time due to methotrexate side effects.
In this study the investigators will examine if adding a drug called glucarpidase to folinic
acid is helpful. Glucarpidase is an enzyme that inactivates methotrexate in the blood
stream. Lower methotrexate concentration in the blood stream leads to fewer side effects.
The investigators would like to see if glucarpidase helps patients to have their
chemotherapy on time, by reducing the side effects of methotrexate.
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze [Completed]
The purpose of this study is to investigate whether the administration of Voraxaze reduces
exposure to leucovorin and its active metabolite to below the level achieved in patients who
have not received Voraxaze.
Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated Wih High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL) [Recruiting]
Early intervention in children and adolescents who experience delayed MTX-clearance and
renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses
MTX to non-toxic metabolites to avoid life threatening complications.
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma [Terminated]
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
Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma [Completed]
RATIONALE: Drugs used in chemotherapy, such as methotrexate and leucovorin, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Glucarpidase may help return the level of methotrexate in the
blood to a safe range. Giving high-dose methotrexate together with glucarpidase and
leucovorin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of methotrexate
when given together with glucarpidase and leucovorin in treating patients with newly
diagnosed primary central nervous system lymphoma.
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