Researchers at the Memorial Sloan Kettering Cancer Center planned to present their findings at an American Academy of Neurology meeting in April which had to be cancelled. The abstract is available on the AAN website here.
High dose methotrexate, a standard treatment for CNSL, is regarded as an efficacious anti-tumor agent, but creates significant risk and burden for patients.
Administration requires aggressive hydration and inpatient monitoring to prevent toxicity. Voraxaze is known to result in a rapid and sustained reduction of serum methotrexate levels(ref) without crossing the blood brain barrier, suggesting there may be a role for Voraxaze as a companion to methotrexate treatment.
In this pilot study, sponsored by Memorial Sloan Kettering Cancer Center in collaboration with the University of Alabama at Birmingham, adult patients with isolated CNSL are treated with rituximab and methotrexate 3 g/m2 or 6 g/m2 administered for eight cycles.
Voraxaze is given 24 hours following start of each methotrexate infusion. Methotrexate concentrations are monitored in serum and cerebrospinal fluid.
Based on the first five patients in the study having received a combined total of 24 doses of methotrexate, researchers shared initial findings that administration of Voraxaze 24 hours after methotrexate results in repeated and consistent rapid reduction of serum methotrexate levels.
In patients analyzed to date, methotrexate levels in the cerebrospinal fluid remain therapeutic and clinical response is seen.
Enrollment in the study is ongoing.
BTG Specialty Pharmaceuticals, a division of Boston Scientific, provides rescue medicines typically used in emergency rooms and intensive care units to treat patients for whom there are limited treatment options.
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