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

University of Medicine and Dentistry of New Jersey

Status

Terminated

Conditions

Neurotoxicity Syndromes

Treatments

Drug: Dextromethorphan

Study type

Interventional

Funder types

Other

Identifiers

NCT00176553

CINJ#110113

3708

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

2 to 21 years old

Volunteers

No 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.