Treatment with Recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with Anaplastic Thyroid Cancer: a proof of concept study

Completed

Conditions: Anaplastic Thyroid Carcinoma
Anaplastic Thyroid Cancer
10043739
10014713

Registration Number: NL-OMON46644

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.;- Patients with proven ATC (cytology or histology), presenting with metastasis not amendable for surgery. ;- age * 18 years

Exclusion Criteria

- unable to give informed consent ;- pregnancy or breast feeding;- neutropenia (absolute neutrophil count (ANC)< 1.5 x10^9/l);- patients with a known history of allergic reactions to compounds of similar chemical or biological composition to Anakinra. ;- Any severe condition which could interfere with participation in this trial, including, but not limited to: severe renal dysfunction (creatinin clearance < 15 ml/min), severe cardiac failure, severe respiratory conditions etc.;- Active infection; However, after adequate treatment of infections, patients will be eligible for inclusion again.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Health related quality of life (HRQoL) defined based on a newly designed HRQoL<br /><br>score specific for ATC patients.<br /><br>Tumor dimensions/ progression defined as tumor volume etc. according to RECIST<br /><br>criteria.<br /><br>Overall Survival (OS) defined as time from official inclusion until death due<br /><br>to any cause. </p><br>

Secondary Outcome Measures

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