Back to resultsNeotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
Primary Purpose
Peripheral Nervous System Diseases, Chemotherapy-Induced Peripheral Neuropathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
leteprinim potassium (Neotrofin)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nervous System Diseases
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.
Sites / Locations
- Alta Bates Comprehensive Cancer Center
- Providence St. Joseph Medical Center
- Providence Holy Cross Medical Center
- Washington University School of Medicine
- NYU Medical Center
- The Sarah Cannon Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00041795
Brief Title
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NeoTherapeutics
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases, Chemotherapy-Induced Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
leteprinim potassium (Neotrofin)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Providence St. Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Providence Holy Cross Medical Center
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12059047
Citation
Grundman M, Farlow M, Peavy G, Kim HT, Capparelli E, Schultz AN, Salmon DP, Ferris SH, Mobs R, Thomas RG, Schafer K, Campbell K, Hake AM, Schoos B, Thal LJ; Alzheimer's Disease Cooperative Study. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci. 2002 Jun;18(3):283-93. doi: 10.1385/jmn:18:3:283.
Results Reference
background
PubMed Identifier
11358452
Citation
Di Iorio P, Virgilio A, Giuliani P, Ballerini P, Vianale G, Middlemiss PJ, Rathbone MP, Ciccarelli R. AIT-082 is neuroprotective against kainate-induced neuronal injury in rats. Exp Neurol. 2001 Jun;169(2):392-9. doi: 10.1006/exnr.2001.7654.
Results Reference
background
PubMed Identifier
10845757
Citation
Rathbone MP, Middlemiss PJ, Gysbers JW, Andrew C, Herman MA, Reed JK, Ciccarelli R, Di Iorio P, Caciagli F. Trophic effects of purines in neurons and glial cells. Prog Neurobiol. 1999 Dec;59(6):663-90. doi: 10.1016/s0301-0082(99)00017-9.
Results Reference
background
PubMed Identifier
8584241
Citation
Middlemiss PJ, Glasky AJ, Rathbone MP, Werstuik E, Hindley S, Gysbers J. AIT-082, a unique purine derivative, enhances nerve growth factor mediated neurite outgrowth from PC12 cells. Neurosci Lett. 1995 Oct 20;199(2):131-4. doi: 10.1016/0304-3940(95)12029-4.
Results Reference
background
Learn more about this trial
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
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