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

NCT ID: NCT00176553

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Neurotoxicity Syndromes

Keywords

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methotrexate neurotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Cancer Institute of New Jersey

Principal Investigators

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Peter Cole, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CINJ#110113

Identifier Type: -

Identifier Source: secondary_id

3708

Identifier Type: -

Identifier Source: org_study_id