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)
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free rate
The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.
at week 12
Viktor Gruenwald, MD
Medical School Hannover
Germany: Federal Institute for Drugs and Medical Devices