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Brief Title: Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
Official Title: 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)
Study ID: NCT01172769
Brief Summary: 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)
Detailed Description: 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. This is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Charitè Berlin Campus Benjamin Franklin Medical Clinic III, Berlin, , Germany
Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology, Duisburg, , Germany
Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch), Essen, , Germany
Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV, Halle, , Germany
Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation, Hannover, , Germany
Universitätsklinikum Jena Clinic for Ear, Nose and Throat, Jena, , Germany
Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat, Leipzig, , Germany
Name: Viktor Gruenwald, MD
Affiliation: Medical School Hannover
Role: PRINCIPAL_INVESTIGATOR