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

2 Years
21 Years
Not Enrolling
Neurotoxicity Syndromes

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Peter Cole, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

March 2003

Completion Date:

May 2007

Related Keywords:

  • Neurotoxicity Syndromes
  • methotrexate neurotoxicity
  • Neurotoxicity Syndromes



Cancer Institute of New Jersey New Brunswick, New Jersey  08901