NCT01172769

Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Temsirolimus	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-07-30
• Last updated: 2013-11-08

Locations

7 sites across 1 country: Germany