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Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041795
First Posted: July 19, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NeoTherapeutics
  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
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

Resource links provided by NLM:


Further study details as provided by NeoTherapeutics:

Estimated Enrollment: 50
Study Start Date: January 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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