Efficacy Study of Temsirolimus to Treat Head and Neck Cancer (TEMHEAD)
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)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Progression free rate [ Time Frame: at week 12 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]time to disease progression
- Toxicity of temsirolimus [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
- Objective response rate [ Time Frame: at week 12 ] [ Designated as safety issue: No ]objective response rate by RECIST
- Overall survival [ Time Frame: at week 12 ] [ Designated as safety issue: No ]overall survival
|Study Start Date:||June 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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.
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.
|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|