Efficacy Study of Temsirolimus to Treat Head and Neck Cancer (TEMHEAD)
This study is currently recruiting participants.
Verified July 2010 by Hannover Medical School
Sponsor:
Hannover Medical School
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01172769
First received: July 7, 2010
Last updated: June 28, 2011
Last verified: July 2010
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Squamous Cell Carcinoma |
Biological: Temsirolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Hannover Medical School:
Primary Outcome Measures:
- Progression free rate [ Time Frame: at week 12 ] [ Designated as safety issue: No ]The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.
Secondary Outcome Measures:
- Time to disease progression [ Time Frame: 6 weeks (average) ] [ Designated as safety issue: No ]time to disease progression
- Toxicity of temsirolimus [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]toxicity of temsirolimus are to be evaluated by CTC 3.0 criteria
- Objective response rate [ Time Frame: at week 12 ] [ Designated as safety issue: No ]objective response rate by RECIST
- Overall survival [ Time Frame: at week 12 ] [ Designated as safety issue: No ]overall survival
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Temsirolimus |
Biological: 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. Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172769
Contacts
| Contact: Viktor Gruenwald, MD | + 49511 532-9196 ext or -4077 | Gruenwald.Viktor@mh-hannover.de |
| Contact: Doris Behrens, MD | + 49511 532-3596 | behrens.doris@mh-hannover.de |
Locations
| Germany | |
| Charitè Berlin Campus Benjamin Franklin Medical Clinic III | Recruiting |
| Berlin, Germany, 12203 | |
| Contact: Ulrich Keilholz, Prof MD +4930-84453906 ulrich.keilholz@charite.de | |
| Principal Investigator: Ulrich Keilholz, Prof MD | |
| Ev. Bethesda- Johanniter Klinikum GmbH Clinic for Heamatology and medical Oncology | Recruiting |
| Duisburg, Germany, 47228 | |
| Contact: Burkhard Hennemann, Prof MD +492065-971508 b.hennemann@johanniter-rheinhausen.de | |
| Principal Investigator: Burkhard Hennemann, Prof MD | |
| Universitaetsklinikum Essen Clinic and Policlinic for internal medicine (Cancerresearch) | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Thomas Gauler, MD +49201-7233159 Thomas.gauler@uni-essen.de | |
| Principal Investigator: Thomas Gauler, MD | |
| Universitätsklinikum Halle Clinic and Policlinic of internal Medicine IV | Recruiting |
| Halle, Germany, 06120 | |
| Contact: Hans-Joachim Schmoll, Prof. MD +49345-5574959 joachim.schmoll@medizin.uni-halle.de | |
| Principal Investigator: Hans-Joachim Schmoll, Prof. MD | |
| Medical School Hannover Clinic for Heamatology, Hemostaseology, Oncology and stem cell transplantation | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: Viktor Gruenwald, MD + 49511-532 9196 Gruenwald.Viktor@mh-hannover.de | |
| Principal Investigator: Viktor Gruenwald, MD | |
| Universitätsklinikum Jena Clinic for Ear, Nose and Throat | Recruiting |
| Jena, Germany, 07743 | |
| Contact: Orlando Guntinas Lichius, Prof. MD +493641-935127 Orlando.Guntinas@med.uni-jena.de | |
| Principal Investigator: Orlando Guntinas Lichius, Prof. MD | |
| Universitätsklinikum Leipzig Clinic and Policlinic for Ear, Nose and Thorat | Recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Andreas Boehm, MD +49341-9716301 andreas.boehm@medizin.uni-leipzig.de | |
| Principal Investigator: Andreas Boehm, MD | |
Sponsors and Collaborators
Hannover Medical School
Investigators
| Principal Investigator: | Viktor Gruenwald, MD | Medical School Hannover |
More Information
No publications provided
| Responsible Party: | MD Viktor Gruenwald, Medical School Hannover |
| ClinicalTrials.gov Identifier: | NCT01172769 History of Changes |
| Other Study ID Numbers: | HN001 |
| Study First Received: | July 7, 2010 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Hannover Medical School:
|
HNSCC |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Sirolimus Everolimus Protein Kinase Inhibitors Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013