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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Temsirolimus
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring HNSCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charitè Berlin Campus Benjamin Franklin Medical Clinic III
  • Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology
  • Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)
  • Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV
  • Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation
  • Universitätsklinikum Jena Clinic for Ear, Nose and Throat
  • Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temsirolimus

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to disease progression
time to disease progression
Toxicity of temsirolimus
toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
Objective response rate
objective response rate by RECIST
Overall survival
overall survival

Full Information

First Posted
July 7, 2010
Last Updated
November 7, 2013
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01172769
Brief Title
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
Acronym
TEMHEAD
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temsirolimus
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Temsirolimus
Other Intervention Name(s)
Torisel, mTOR inhibitor, protein kinase inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free rate
Description
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 Frame
at week 12
Secondary Outcome Measure Information:
Title
Time to disease progression
Description
time to disease progression
Time Frame
6 weeks (average)
Title
Toxicity of temsirolimus
Description
toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
Time Frame
12 weeks
Title
Objective response rate
Description
objective response rate by RECIST
Time Frame
at week 12
Title
Overall survival
Description
overall survival
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Gruenwald, MD
Organizational Affiliation
Medical School Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charitè Berlin Campus Benjamin Franklin Medical Clinic III
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology
City
Duisburg
ZIP/Postal Code
47228
Country
Germany
Facility Name
Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Jena Clinic for Ear, Nose and Throat
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25527417
Citation
Grunwald V, Keilholz U, Boehm A, Guntinas-Lichius O, Hennemann B, Schmoll HJ, Ivanyi P, Abbas M, Lehmann U, Koch A, Karch A, Zorner A, Gauler TC. TEMHEAD: a single-arm multicentre phase II study of temsirolimus in platin- and cetuximab refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) of the German SCCHN Group (AIO). Ann Oncol. 2015 Mar;26(3):561-7. doi: 10.1093/annonc/mdu571. Epub 2014 Dec 19.
Results Reference
derived

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Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

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