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Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00041795
Recruitment Status : Completed
First Posted : July 19, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NeoTherapeutics

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

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2002

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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