Head and Neck Squamous Cell CarcinomaPhase 2TEMHEADNCT01172769
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
A Phase 2 study testing Temsirolimus in people with Head and Neck Squamous Cell Carcinoma, run by Hannover Medical School at 7 sites in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesGermany
- Study dates
- Jun 2010to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Charitè Berlin Campus Benjamin Franklin Medical Clinic III
Berlin, 12203
Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology
Duisburg, 47228
Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)
Essen, 45147
Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV
Halle, 06120
Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation
Hanover, 30625
Universitätsklinikum Jena Clinic for Ear, Nose and Throat
Jena, 07743
Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat
Leipzig, 04103
About this study
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)
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)
Read the 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
- Being tested
- Temsirolimus
- Keywords
- HNSCC
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusBiological
Also called Torisel, mTOR inhibitor, protein kinase inhibitor
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.
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | Not described Receives: Biological: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 12
Secondary outcomes (4)
Time to disease progression
time to disease progression
Measured: 6 weeks (average)
Toxicity of temsirolimus
toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
Measured: 12 weeks
Objective response rate
objective response rate by RECIST
Measured: at week 12
Overall survival
overall survival
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Grünwald, Hannover Medical School
- Investigators
- Viktor Gruenwald, MD, Principal investigator, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172769
- Sponsor's protocol ID
- HN001
- Acronym
- TEMHEAD
- Status last verified
- Nov 2013
- First submitted
- 7 Jul 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25527417
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01172769
- Acronym / sponsor ID
- TEMHEAD / HN001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- HNSCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Biological: Temsirolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusAlso: Torisel, mTOR inhibitor, protein kinase inhibitorAfter 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. | Biological | Temsirolimus |
Primary outcome
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.
4 secondary outcomes
Time to disease progression
Time frame: 6 weeks (average)
Toxicity of temsirolimus
Time frame: 12 weeks
Objective response rate
Time frame: at week 12
Overall survival
Time frame: at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Derived from this study: PubMed 25527417Grunwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor Gruenwald, MD principal investigator
Medical School Hannover
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temsirolimus in people with Head and Neck Squamous Cell Carcinoma, run by Hannover Medical School at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free rate (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.