Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

NCT01172769 | Completed Phase 2

• 1 other identifier: HN001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

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)

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 12

Secondary Outcomes (4)

• Time to disease progression

  6 weeks (average)

• Toxicity of temsirolimus

  12 weeks

• Objective response rate

  at week 12

• Overall survival

  at week 12

Study Arms (1)

Temsirolimus

EXPERIMENTAL

Biological: Temsirolimus

Interventions

Temsirolimus 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.

Also known as: Torisel, mTOR inhibitor, protein kinase inhibitor

Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (7)

Charitè Berlin Campus Benjamin Franklin Medical Clinic III

Berlin, 12203, Germany

Location

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

Duisburg, 47228, Germany

Location

Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch)

Essen, 45147, Germany

Location

Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV

Halle, 06120, Germany

Location

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

Hanover, 30625, Germany

Location

Universitätsklinikum Jena Clinic for Ear, Nose and Throat

Jena, 07743, Germany

Location

Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat

Leipzig, 04103, Germany

Location

Related Publications (1)

• 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.

  PMID: 25527417 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

temsirolimus; Sirolimus; Protein Kinase Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Viktor Gruenwald, MD

  Medical School Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 30, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

DE (7)