A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
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ClinicalTrials.gov Identifier: NCT00176553
Recruitment Status :
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
University of Medicine and Dentistry of New Jersey
The purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.
Condition or disease
We believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. Dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. We have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. All had a complete recovery within one day.
Patients will receive an inert carrier with or without dextromethorphan. The study drug will be administered at 1.5 mg/kg/dose on a BID schedule. The first dose to be given prior to each scheduled intravenous and/or intrathecal administration of methotrexate and continued for a total of seven days.
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Ages Eligible for Study:
2 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Newly diagnosed acute lymphocytic leukemia (ALL), non-Hodgkin's lymphoma (NHL) or OS. Patients will be separately stratified and randomized by disease.
Patients with history of seizures are eligible but will be stratified separately.
Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.