Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

NCT ID: NCT01172769

Last Updated: 2013-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temsirolimus

Group Type: EXPERIMENTAL

Temsirolimus

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Torisel; mTOR inhibitor; protein kinase inhibitor

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Viktor Grünwald

Associate Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktor Gruenwald, MD

Role: PRINCIPAL_INVESTIGATOR

Medical School Hannover

Locations

Charitè Berlin Campus Benjamin Franklin Medical Clinic III

Berlin, , Germany

Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology

Duisburg, , Germany

Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)

Essen, , Germany

Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV

Halle, , Germany

Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation

Hanover, , Germany

Universitätsklinikum Jena Clinic for Ear, Nose and Throat

Jena, , Germany

Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat

Leipzig, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25527417 (View on PubMed)

Other Identifiers

HN001

Identifier Type: -

Identifier Source: org_study_id