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

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ClinicalTrials.gov Identifier: NCT00176553
Recruitment Status : Terminated (slow accrual)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Neurotoxicity Syndromes Drug: Dextromethorphan

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Study Start Date : March 2003
Primary Completion Date : May 2007
Study Completion Date : May 2007

Arms and Interventions

Intervention Details:
    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

Primary Outcome Measures :
  1. To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176553

United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Peter Cole, MD Rutgers, The State University of New Jersey
More Information

Responsible Party: Peter Cole, Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00176553     History of Changes
Other Study ID Numbers: 3708
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009

Keywords provided by Rutgers, The State University of New Jersey:
methotrexate neurotoxicity

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Nervous System Diseases
Chemically-Induced Disorders
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents