Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041795
• Other study ID #: 082-2001-005
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2002
• Last updated: June 23, 2005
• Start date: January 2002

Study information

• Verified date: July 2002
• Source: NeoTherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

Drug:
• leteprinim potassium (Neotrofin)

Locations

Country	Name	City	State
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Providence Holy Cross Medical Center	Mission Hills	California
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	NYU Medical Center	New York	New York
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
NeoTherapeutics

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation