A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
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...
Brief Summary
Official Title: “A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: May 2007
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- Drug: Dextromethorphan
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
- Time Frame: 5 years
Safety Issue?: No
- Time Frame: 5 years
Secondary Measures
- To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate
- Time Frame: 5 years
Safety Issue?: No
- Time Frame: 5 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.
- Pregnant or lactating women.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: 21 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of Medicine and Dentistry New Jersey Other
Overall Clinical Trial Officials and Contacts
Peter Cole, MD Principal Investigator University of Medicine and Dentistry New Jersey
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00176553
Study ID Number: 3708
ClinicalTrials.gov Identifier: NCT00176553
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00176553
