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
  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:


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
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, see Learn About Clinical Studies.

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