Trial Information
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
082-2001-005
NCT ID:
NCT00041795
Start Date:
January 2002
Completion Date:
Related Keywords:
- Peripheral Nervous System Diseases
- Chemotherapy-Induced Peripheral Neuropathy
- Nervous System Diseases
- Peripheral Nervous System Diseases
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
- Neurotoxicity Syndromes
Name | Location |
|---|
| Washington University School of Medicine |
Saint Louis, Missouri 63110 |
| Alta Bates Comprehensive Cancer Center |
Berkeley, California 94704 |
| The Sarah Cannon Cancer Center |
Nashville, Tennessee 37203 |
| NYU Medical Center |
New York, New York 10016 |
| Providence St. Joseph Medical Center |
Burbank, California 91505 |
| Providence Holy Cross Medical Center |
Mission Hills, California 91345 |
