A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00176553

Enrollment

Registered

2005-09-15

Start date

2003-03-31

Completion date

2007-05-31

Last updated

2009-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotoxicity Syndromes

Keywords

methotrexate neurotoxicity

Brief summary

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.

Detailed 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.

Interventions

DRUGDextromethorphan

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate	5 years

Secondary

Measure	Time frame
To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026