Trial record 5 of 549 for:
A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
This study has been terminated.
Information provided by:
Rutgers, The State University of New Jersey
First received: September 12, 2005
Last updated: December 10, 2009
Last verified: December 2009
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.
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity
Primary Outcome Measures:
- To determine whether dextromethorphan decreases the subacute toxicities associated with intravenous and intrathecal methotrexate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine whether dextromethorphan can alleviate acute or subacute neurotoxicity when it does occur after intravenous or intrathecal methotrexate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2007 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||2 Years to 21 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions.
- Pregnant or lactating women.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176553
|Cancer Institute of New Jersey
|New Brunswick, New Jersey, United States, 08901 |
University of Medicine and Dentistry New Jersey
||Peter Cole, MD
||Rutgers, The State University of New Jersey
No publications provided
||Peter Cole, Cancer Institute of New Jersey
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||December 10, 2009
||United States: Institutional Review Board
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Nervous System Diseases
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Agents
Respiratory System Agents
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors