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

Neurotoxicity Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176553
• Other study ID #: 3708
• Secondary ID: CINJ#110113
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 10, 2009
• Start date: March 2003
• Est. completion date: May 2007

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neurotoxicity Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate		5 years	No
Secondary	To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate		5 years	No