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

• Sponsor: University of Medicine and Dentistry of New Jersey (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00176553
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurotoxicity Syndromes	Drug: Dextromethorphan	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate [5 years]

Secondary Outcome Measures

1. To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• University of Medicine and Dentistry of New Jersey

Investigators

• Principal Investigator: Peter Cole, MD, Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00176553
• Other Study ID Numbers: 3708; CINJ#110113
• First Posted: Sep 15, 2005
• Last Update Posted: Dec 11, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: methotrexate neurotoxicity
• Additional relevant MeSH terms: Neurotoxicity Syndromes; Dextromethorphan

Study Results

No Results Posted as of Dec 11, 2009