Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 11:03 AM
Study NCT ID:
NCT01172769
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2010-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2010-07-07', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free rate', 'timeFrame': 'at week 12', 'description': 'The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression', 'timeFrame': '6 weeks (average)', 'description': 'time to disease progression'}, {'measure': 'Toxicity of temsirolimus', 'timeFrame': '12 weeks', 'description': 'toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria'}, {'measure': 'Objective response rate', 'timeFrame': 'at week 12', 'description': 'objective response rate by RECIST'}, {'measure': 'Overall survival', 'timeFrame': 'at week 12', 'description': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HNSCC'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '25527417', 'type': 'DERIVED', 'citation': 'Grunwald V, Keilholz U, Boehm A, Guntinas-Lichius O, Hennemann B, Schmoll HJ, Ivanyi P, Abbas M, Lehmann U, Koch A, Karch A, Zorner A, Gauler TC. TEMHEAD: a single-arm multicentre phase II study of temsirolimus in platin- and cetuximab refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) of the German SCCHN Group (AIO). Ann Oncol. 2015 Mar;26(3):561-7. doi: 10.1093/annonc/mdu571. Epub 2014 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)', 'detailedDescription': 'Temsirolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a crucial regulator of cell cycle progression. It was approved in the treatment of advanced renal cell carcinoma. Temsirolimus demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. A similar effect was noted in HNSCC cell lines.\n\nThis is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent must be given prior to study inclusion\n* Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)\n* Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy\n* Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion\n* Cetuximab must have been included in at least one prior line of therapy\n* Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy\n* At least one measurable lesion according to RECIST (Version 1.0) criteria\n* Age \\> 18 years\n* ECOG performance status 0-2\n* Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment\n* If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose\n* Willingness and ability to comply with the protocol\n* Adequate bone marrow function, liver and renal function\n\nExclusion Criteria:\n\n* Live expectancy less than 3 months\n* Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery\n* Participation in a clinical trial within the last 30 days prior to study treatment\n* Serious illness or medical condition other than the disease under study\n* Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix\n* Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons\n* Pregnancy or breast feeding\n* Known allergic/hypersensitivity reaction to any component of the treatment\n* Concurrent treatment with oral anticoagulants\n* Uncontrolled diabetes: fasting serum glucose \\> 2.0 ULN\n* Active or uncontrolled infection'}, 'identificationModule': {'nctId': 'NCT01172769', 'acronym': 'TEMHEAD', 'briefTitle': 'Efficacy Study of Temsirolimus to Treat Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'A Single Arm, Open-label Multicenter Phase II Trial of Temsirolimus in Patients With Relapsed/Recurrent Squamous Cell Cancer of the Head and Neck (HNSCC)', 'orgStudyIdInfo': {'id': 'HN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temsirolimus', 'interventionNames': ['Biological: Temsirolimus']}], 'interventions': [{'name': 'Temsirolimus', 'type': 'BIOLOGICAL', 'otherNames': ['Torisel', 'mTOR inhibitor', 'protein kinase inhibitor'], 'description': 'After dissolving and dilution 25 mg of temsirolimus will be administered i.v. once a week by 30 minute infusion.\n\nStudy treatment will continue until tumor progression or unless unacceptable toxicity is encountered.', 'armGroupLabels': ['Temsirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charitè Berlin Campus Benjamin Franklin Medical Clinic III', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '47228', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena Clinic for Ear, Nose and Throat', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Viktor Gruenwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor MD', 'investigatorFullName': 'Viktor Grünwald', 'investigatorAffiliation': 'Hannover Medical School'}}}}