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

Primary Purpose

Neurotoxicity Syndromes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurotoxicity Syndromes focused on measuring methotrexate neurotoxicity

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Institute of New Jersey

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate

Full Information

First Posted
September 12, 2005
Last Updated
December 10, 2009
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00176553
Brief Title
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Official Title
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
March 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity Syndromes
Keywords
methotrexate neurotoxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cole, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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