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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment

Study Primary Completion Date: May 2007

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.

Primary Measures

• To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
  • Time Frame: 5 years
    Safety Issue?: No

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

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

Lead Sponsor: University of Medicine and Dentistry New Jersey

Overall Clinical Trial Officials and Contacts

Peter Cole, MD Principal Investigator University of Medicine and Dentistry New Jersey  

Information obtained from ClinicalTrials.gov on July 02, 2009

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