Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

This study has been completed.

Sponsor:

Information provided by:

NeoTherapeutics

ClinicalTrials.gov Identifier:

NCT00041795

First received: July 16, 2002

Last updated: June 23, 2005

Last verified: July 2002

History of Changes

Purpose

This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.

Condition	Intervention	Phase
Peripheral Nervous System Diseases Chemotherapy-Induced Peripheral Neuropathy	Drug: leteprinim potassium (Neotrofin)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Cancer Neurologic Diseases Peripheral Nerve Disorders Potassium

U.S. FDA Resources

Further study details as provided by NeoTherapeutics:

Estimated Enrollment:	50
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041795

Locations

United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
Providence Holy Cross Medical Center
Mission Hills, California, United States, 91345
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
NYU Medical Center
New York, New York, United States, 10016
United States, Tennessee
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

NeoTherapeutics

More Information

Publications:

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. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci. 2002 Jun;18(3):283-93.

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.

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. Review.

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.

ClinicalTrials.gov Identifier:	NCT00041795 History of Changes
Other Study ID Numbers:	082-2001-005
Study First Received:	July 16, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Nervous System Diseases
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations

Neurotoxicity Syndromes
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013

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