Clinical trial NCT01172769: Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: HNSCC
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression free rate
timeFrame: at week 12
Secondary outcomes:
measure: Time to disease progression
timeFrame: 6 weeks (average)
measure: Toxicity of temsirolimus
timeFrame: 12 weeks
measure: Objective response rate
timeFrame: at week 12
measure: Overall survival
timeFrame: at week 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charitè Berlin Campus Benjamin Franklin Medical Clinic III
city: Duisburg
country: Germany
facility: Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology
city: Essen
country: Germany
facility: Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)
city: Halle
country: Germany
facility: Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV
city: Hannover
country: Germany
facility: Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation
city: Jena
country: Germany
facility: Universitätsklinikum Jena Clinic for Ear, Nose and Throat
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat
Study officials:
affiliation: Medical School Hannover
name: Viktor Gruenwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.