Treatment with recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with anaplastic thyroid cancer: a proof of concept study

Conditions: anaplastic thyroid carcinoma

Registration Number: NL-OMON22269

Lead Sponsor: Radboud UMC Nijmegen, The Netherlands

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

newly diagnosed patients with a proven diagnosis (cytology or histology) of ATC, for whom surgery is not feasible (as documented after consultation in multidisciplinary tumor board).

- Patients with proven ATC (cytology or histology), presenting with metastasis not amendable for surgery.

Exclusion Criteria

- unable to give informed consent

- pregnancy or breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primairy endpoints well be: <br /><br>- Effect of anakinra on health related quality of life (HRQoL), HR QoL defined according to a newly developed HRQoL questionaire specifically for ATC patients. <br /><br>- Effects on tumor progression/tumor extent, such as TNM classification and tumor size. This will be assessed using radiological examinations using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria . <br /><br>- Overall Survival (OS): defined as time interval from date of official inclusion to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of treatment with IL1Ra (Anakinra) in patients with anaplastic TC on: <br /><br>- performance status, measured with the Eastern Cooperative Oncology Group (ECOG) performance scale. <br /><br>- progression free survival (PFS): which is defined as the time interval from date of official inclusioin to date of first progression or death due to any cause, if death occurs before<br>a progression is documented. Progression will be defined according to RECIST criteria. <br /><br>- safety in terms of occurrence and severity of adverse events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) (35), - Measurements of (systemic) inflammation, e.g. CRP, IL6 serum levels, etc.