Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-27 @ 5:15 PM
Study NCT ID:
NCT00041795
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C086241', 'term': '4-((3-(1,6-dihyro-6-oxo-9H-purin-9-yl)-1-oxopropyl)amino)benzoic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'statusVerifiedDate': '2002-07', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2002-07-16', 'studyFirstSubmitQcDate': '2002-07-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-07-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Peripheral Nervous System Diseases', 'Chemotherapy-Induced Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '12059047', 'type': 'BACKGROUND', '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."}, {'pmid': '11358452', 'type': 'BACKGROUND', '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.'}, {'pmid': '10845757', 'type': 'BACKGROUND', '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.'}, {'pmid': '8584241', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy.\n* Sensory or motor neuropathy must be \\>/= grade 2 per Common Toxicity Criteria at baseline.\n* In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable.\n* Patient must have normal hematological cell counts.\n* Patient must have a life expectancy of \\>/= 3 months.'}, 'identificationModule': {'nctId': 'NCT00041795', 'briefTitle': 'Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeoTherapeutics'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer', 'orgStudyIdInfo': {'id': '082-2001-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'leteprinim potassium (Neotrofin)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St. Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Providence Holy Cross Medical Center', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeoTherapeutics', 'class': 'INDUSTRY'}}}}