Efficacy Study of Temsirolimus to Treat Head and Neck Cancer (TEMHEAD)
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|ClinicalTrials.gov Identifier: NCT01172769|
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : November 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Biological: Temsirolimus||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
After dissolving and dilution 25 mg of temsirolimus will be administered i.v. once a week by 30 minute infusion.
Study treatment will continue until tumor progression or unless unacceptable toxicity is encountered.
- Progression free rate [ Time Frame: at week 12 ]The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.
- Time to disease progression [ Time Frame: 6 weeks (average) ]time to disease progression
- Toxicity of temsirolimus [ Time Frame: 12 weeks ]toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
- Objective response rate [ Time Frame: at week 12 ]objective response rate by RECIST
- Overall survival [ Time Frame: at week 12 ]overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172769
|Charitè Berlin Campus Benjamin Franklin Medical Clinic III|
|Berlin, Germany, 12203|
|Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology|
|Duisburg, Germany, 47228|
|Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)|
|Essen, Germany, 45147|
|Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV|
|Halle, Germany, 06120|
|Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation|
|Hannover, Germany, 30625|
|Universitätsklinikum Jena Clinic for Ear, Nose and Throat|
|Jena, Germany, 07743|
|Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat|
|Leipzig, Germany, 04103|
|Principal Investigator:||Viktor Gruenwald, MD||Medical School Hannover|