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

Treatment with Recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with Anaplastic Thyroid Cancer: a proof of concept study - ATC-Anakinra1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46644

Enrollment

Registered

2018-03-06

Start date

2018-10-16

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaplastic Thyroid Carcinoma

Interventions

IL1Ra (anakinra, Kineret ©) 600 mg/d i.v. for 1 week, followed by 100 mg/d s.c. for a total of 6 months

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To investigate the effect of treatment with IL1Ra (Anakinra) in patients with anaplastic TC on: - performance status, measured with the Eastern Cooperative Oncology Group (ECOG) performance scale. - 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 a progression is documented. Progression will be defined according to RECIST criteria. - 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.	—

Measure

Time frame

To investigate the effect of treatment with IL1Ra (Anakinra) in patients with anaplastic TC on: - performance status, measured with the Eastern Cooperative Oncology Group (ECOG) performance scale. - 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 a progression is documented. Progression will be defined according to RECIST criteria. - 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)