Clinical trial · Interventional
Efficacy Study of Temsirolimus to Treat Head and Neck Cancer
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)
NCT01172769CI-TRIAL-00012610TEMHEADcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temsirolimus | Biological | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temsirolimus
- interventionNames
- Biological: Temsirolimus
Primary outcomes (1)
- measure
- Progression free rate
- timeFrame
- at week 12
- description
- 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 outcomes (4)
- measure
- Time to disease progression
- timeFrame
- 6 weeks (average)
- description
- time to disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGrunwald 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