A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
2 Years
21 Years
Both
Neurotoxicity Syndromes
Trial Information
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Peter Cole, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Medicine and Dentistry New Jersey
Authority:
United States: Institutional Review Board
Study ID:
3708
NCT ID:
NCT00176553
Start Date:
March 2003
Completion Date:
May 2007
Related Keywords:
- Neurotoxicity Syndromes
- methotrexate neurotoxicity
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
