Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT01149902
Status:
UNKNOWN
Last Update Posted:
2011-08-24
First Post:
2010-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D010844', 'term': 'Picibanil'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2010-06-22', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and feasibility of chemo-immunotherapy', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The number and function of immune effector cells in treated patients', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients with relapsed and refractory head and neck squamous cell carcinoma\n2. 20 years and older\n3. ECOG performance status 0-1\n4. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy\n5. Tumor lesions are accessible to intratumoral dendritic cells injection\n6. Patients who are able to do oral ingestion\n7. Patients must have normal organ and marrow functions as follows:\n\n * Hb\\>9.0 mg/dl\n * Ht\\>25%\n * WBC\\>4000/mm3\n * Platelet count\\>100,000/mm3\n * T-Bil\\<1.5mg/dl\n * GOT\\<x2.5 institutional upper limit of normal\n * GPT\\<x2.5 institutional upper limit of normal\n * Creatinin\\<1.5mg/dl\n8. signed informed consent\n\nExclusion Criteria:\n\n1. Less than 20 years\n2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.\n3. Patients with clinically active infection\n4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency\n5. Concomitant malignant diseases, brain metastases\n6. Psychiatric illness\n7. Treatment with steroids\n8. Decision of unsuitableness by physician'}, 'identificationModule': {'nctId': 'NCT01149902', 'briefTitle': 'Study of Chemo-Immunotherapy in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Yamanashi'}, 'officialTitle': 'Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '631'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cyclophosphamide, Docetaxel, Dendritic cells, OK-432', 'type': 'BIOLOGICAL', 'description': 'Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35'}]}, 'contactsLocationsModule': {'locations': [{'zip': '409-3898', 'city': 'Chūō', 'state': 'Yamanashi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroki Ishii, MD', 'role': 'CONTACT', 'email': 'ishiih@yamanashi.ac.jp', 'phone': '+81-55-273-6769'}, {'name': 'Keisuke Masuyama, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Umiversity of Yamanashi Hospital', 'geoPoint': {'lat': 35.59465, 'lon': 138.50275}}], 'centralContacts': [{'name': 'Hiroki Ishii, MD', 'role': 'CONTACT', 'email': 'ishiih@yamanashi.ac.jp', 'phone': '+81-55-273-6769'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Yamanashi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Keisuke Masuyama, Professor', 'oldOrganization': 'Department of Otolaryngology-Head and Neck Surgery, University of Yamanashi, Faculty of Medicine'}}}}