Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-28 @ 6:13 PM
Study NCT ID:
NCT00250120
Status:
WITHDRAWN
Last Update Posted:
2016-05-12
First Post:
2005-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacology Study of Aerosolized Liposomal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological examination of lung tissure', 'timeFrame': 'at surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'L9NC', 'Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin'], 'conditions': ['Lung Diseases', 'Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization in patients with non-small-cell lung cancer (any stage).\n\nTo determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks, every 10 weeks.\n\nTo perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A specific protocol will be written for this part.', 'detailedDescription': 'This is a single-arm, non-randomized Phase II trial of DLPC-9NC administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks.\n\nDose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks.\n\nPatients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients participating in INST 1402C protocol\n* Phase II Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients with Advanced (NSCLC) Lung Cancer are eligible if their tumor is resectable with curative intent as determined by Dr. Reza Mehran.'}, 'identificationModule': {'nctId': 'NCT00250120', 'briefTitle': 'Pharmacology Study of Aerosolized Liposomal', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)', 'orgStudyIdInfo': {'id': '1402C-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin', 'type': 'DRUG', 'description': 'delivery mode: inhalation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Claire F Verschraegen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Claire Verschraegen, MD; Principal Investigator', 'oldOrganization': 'Universtiy of New Mexico - CRTC'}}}}