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Efficacy Study of Temsirolimus to Treat Head and Neck Cancer (TEMHEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172769
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):
Viktor Grünwald, Hannover Medical School

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)

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Biological: Temsirolimus Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Temsirolimus 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.

Other Names:
  • Torisel
  • mTOR inhibitor
  • protein kinase inhibitor

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: 6 weeks (average) ]
    time to disease progression

  2. Toxicity of temsirolimus [ Time Frame: 12 weeks ]
    toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria

  3. Objective response rate [ Time Frame: at week 12 ]
    objective response rate by RECIST

  4. Overall survival [ Time Frame: at week 12 ]
    overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent must be given prior to study inclusion
  • Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
  • Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
  • Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
  • Cetuximab must have been included in at least one prior line of therapy
  • Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
  • At least one measurable lesion according to RECIST (Version 1.0) criteria
  • Age > 18 years
  • ECOG performance status 0-2
  • Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
  • If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
  • Willingness and ability to comply with the protocol
  • Adequate bone marrow function, liver and renal function

Exclusion Criteria:

  • Live expectancy less than 3 months
  • Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
  • Participation in a clinical trial within the last 30 days prior to study treatment
  • Serious illness or medical condition other than the disease under study
  • Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
  • Pregnancy or breast feeding
  • Known allergic/hypersensitivity reaction to any component of the treatment
  • Concurrent treatment with oral anticoagulants
  • Uncontrolled diabetes: fasting serum glucose > 2.0 ULN
  • Active or uncontrolled infection

Information from the National Library of Medicine

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 identifier (NCT number): NCT01172769

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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
Sponsors and Collaborators
Hannover Medical School
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Principal Investigator: Viktor Gruenwald, MD Medical School Hannover

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Viktor Grünwald, Associate Professor MD, Hannover Medical School Identifier: NCT01172769     History of Changes
Other Study ID Numbers: HN001
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
Keywords provided by Viktor Grünwald, Hannover Medical School:
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Enzyme Inhibitors
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Molecular Mechanisms of Pharmacological Action