Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

NCT00041795 | Completed Phase 2

• 1 other identifier: 082-2001-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Peripheral Nervous System Diseases; Chemotherapy-Induced Peripheral Neuropathy

Interventions

leteprinim potassium (Neotrofin) DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NeoTherapeutics: lead

Study Sites (6)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

Providence Holy Cross Medical Center

Mission Hills, California, 91345, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

The Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (4)

• 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.

  PMID: 12059047 BACKGROUND

• 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.

  PMID: 11358452 BACKGROUND

• 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.

  PMID: 10845757 BACKGROUND

• 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.

  PMID: 8584241 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

4-((3-(1,6-dihyro-6-oxo-9H-purin-9-yl)-1-oxopropyl)amino)benzoic acid

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2002
• First Posted: July 19, 2002
• Study Start: January 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2002-07

Locations

US (6)