Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy - Full Text View

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Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

This study has been completed.

First Received: July 16, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	NeoTherapeutics
Information provided by:	NeoTherapeutics
ClinicalTrials.gov Identifier:	NCT00041795

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Neurologic Diseases Peripheral Nerve Disorders

Drug Information available for: Leteprinim potassium

Further study details as provided by NeoTherapeutics:

Estimated Enrollment:	50
Study Start Date:	January 2002

Eligibility

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
Providence St. Joseph Medical Center
Burbank, California, United States, 91505
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
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:

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

Additional relevant MeSH terms:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 08, 2010