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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Viktor Grünwald, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01172769
First received: July 7, 2010
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Head and Neck Squamous Cell Carcinoma
Biological: Temsirolimus
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 42
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172769

Locations
Germany
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
Investigators
Principal Investigator: Viktor Gruenwald, MD Medical School Hannover
  More Information

No publications provided

Responsible Party: Viktor Grünwald, Associate Professor MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01172769     History of Changes
Other Study ID Numbers: HN001
Study First Received: July 7, 2010
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
HNSCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Sirolimus
Everolimus
Protein Kinase Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014