Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
NCT ID: NCT00041795
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2002-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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leteprinim potassium (Neotrofin)
Eligibility Criteria
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Inclusion Criteria
* Sensory or motor neuropathy must be \>/= grade 2 per Common Toxicity Criteria at baseline.
* In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable.
* Patient must have normal hematological cell counts.
* Patient must have a life expectancy of \>/= 3 months.
18 Years
80 Years
ALL
No
Sponsors
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NeoTherapeutics
INDUSTRY
Locations
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Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Providence Holy Cross Medical Center
Mission Hills, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Medical Center
New York, New York, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Countries
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References
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Grundman M, Farlow M, Peavy G, Kim HT, Capparelli E, Schultz AN, Salmon DP, Ferris SH, Mobs R, Thomas RG, Schafer K, Campbell K, Hake AM, Schoos B, Thal LJ; Alzheimer's Disease Cooperative Study. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci. 2002 Jun;18(3):283-93. doi: 10.1385/jmn:18:3:283.
Di Iorio P, Virgilio A, Giuliani P, Ballerini P, Vianale G, Middlemiss PJ, Rathbone MP, Ciccarelli R. AIT-082 is neuroprotective against kainate-induced neuronal injury in rats. Exp Neurol. 2001 Jun;169(2):392-9. doi: 10.1006/exnr.2001.7654.
Rathbone MP, Middlemiss PJ, Gysbers JW, Andrew C, Herman MA, Reed JK, Ciccarelli R, Di Iorio P, Caciagli F. Trophic effects of purines in neurons and glial cells. Prog Neurobiol. 1999 Dec;59(6):663-90. doi: 10.1016/s0301-0082(99)00017-9.
Middlemiss PJ, Glasky AJ, Rathbone MP, Werstuik E, Hindley S, Gysbers J. AIT-082, a unique purine derivative, enhances nerve growth factor mediated neurite outgrowth from PC12 cells. Neurosci Lett. 1995 Oct 20;199(2):131-4. doi: 10.1016/0304-3940(95)12029-4.
Other Identifiers
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082-2001-005
Identifier Type: -
Identifier Source: org_study_id