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

Hannover Medical School (MHH)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Biological: Temsirolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01172769

HN001

Details and patient eligibility

About

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)

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No 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