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

Not Applicable

Terminated

• Conditions: Neurotoxicity Syndromes

• Registration Number: NCT00176553
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States