Not Signed In -
Potassium Chloride Effervescent |
Effer-K; Effervescent Potassium; Gen-K Powder; K+ Care; K-Lor Powder; K-Lyte; K-Lyte/Cl; Kay Ciel Powder; Klor-Con/EF; Klorvess |
Clinical Trial: Neotrofin for treatment of chemotherapy-induced peripheral neuropathy
This study has been completed.
|
Purpose
This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Peripheral Nervous System Diseases Chemotherapy-Induced Peripheral Neuropathy | Drug: leteprinim potassium (Neotrofin) | Phase II |
MedlinePlus related topics: Peripheral Nerve Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 50
Study start: January 2002
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
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.
Location Information
California
Providence St. Joseph Medical Center, Burbank, California, 91505, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, 94704, United States
Providence Holy Cross Medical Center, Mission Hills, California, 91345, United States
Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States
New York
NYU Medical Center, New York, New York, 10016, United States
Tennessee
The Sarah Cannon Cancer Center, Nashville, Tennessee, 37203, United States
More Information
Publications
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. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci. 2002 Jun;18(3):283-93.
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.
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.
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.
Record last reviewed: July 2002
Last Updated: January 28, 2005
Record first received: July 16, 2002
ClinicalTrials.gov Identifier: NCT00041795
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Effer-K (Drug Digest)
- Effervescent Potassium (Drug Digest)
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