Treatment with Anakinra for patients with anaplastic thyroid cancer

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003028-59-NL

Enrollment

Registered

2018-03-06

Start date

2018-06-06

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Anaplastic Thyroid Carcinoma

Interventions

Trade Name: Kineret Product Name: Kineret Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe

Eligibility

Sex/Gender

All

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

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
Main Objective: To investigate the effect of treatment with human recombinant IL1Ra (rhIL1Ra, Anakinra) on health related quality of life (HRQoL), tumor progression and overall survival in patients with anaplastic thyroid carcinoma. ;Secondary Objective: To investigate the effect of treatment with IL1Ra (Anakinra) in patients with ATC 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 diagnosis 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. ;Primary end point(s): Health Related Quality of Life (HR-QoL): defined as outcome of the QoL life questionnaire specifically designed for anaplastic thyroid cancer patients Tumor dimensions/tumor progression: TNM classification and tumor size etc. This will be assessed using radiological examinations using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria . Overall survival (OS): defined as time interval from date of official inclusion to death due to any cause. ;Timepoint(s) of evaluation of this end point: 4, 8 , 12 and 24 weeks after start of treatment imaging studie and laboratory tests to assess tumor status/tumor progression bi-weekly QoL questionaires .	—

Measure

Time frame

Main Objective: To investigate the effect of treatment with human recombinant IL1Ra (rhIL1Ra, Anakinra) on health related quality of life (HRQoL), tumor progression and overall survival in patients with anaplastic thyroid carcinoma. ;Secondary Objective: To investigate the effect of treatment with IL1Ra (Anakinra) in patients with ATC 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 diagnosis 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. ;Primary end point(s): Health Related Quality of Life (HR-QoL): defined as outcome of the QoL life questionnaire specifically designed for anaplastic thyroid cancer patients Tumor dimensions/tumor progression: TNM classification and tumor size etc. This will be assessed using radiological examinations using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria . Overall survival (OS): defined as time interval from date of official inclusion to death due to any cause. ;Timepoint(s) of evaluation of this end point: 4, 8 , 12 and 24 weeks after start of treatment imaging studie and laboratory tests to assess tumor status/tumor progression bi-weekly QoL questionaires .

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Secondary

Measure	Time frame
Secondary end point(s): - Improved quality of life (QoL): defined as outcome of the QoL life questionnaire specifically designed for thyroid cancer patients, the THYCA-QoL in combination with the EORTC QLQ-C30. - The Eastern Cooperative Oncology Group (ECOG) performance status. - Progression free survival (PFS) based on imaging studies according to RECIST. - Effect of anakinra on Inflammatory parameters: • Systemic: CRP, fibrogen, feirritin, triglycerides, albumin, alfa-1-antitripsin, leukocyte counts, IL-6 levels • Cellular level: quantification and phenotyping of circulating immune cell populations; cytokine production in Peripheral Blood Mononuclear Cells (PBMCs). ;Timepoint(s) of evaluation of this end point: 4, 8 , 12 and 24 weeks after start of treatment imaging studies to assess tumor status/tumor progression every month QoL questionaires and blood donations.	—

Measure

Time frame

Secondary end point(s): - Improved quality of life (QoL): defined as outcome of the QoL life questionnaire specifically designed for thyroid cancer patients, the THYCA-QoL in combination with the EORTC QLQ-C30. - The Eastern Cooperative Oncology Group (ECOG) performance status. - Progression free survival (PFS) based on imaging studies according to RECIST. - Effect of anakinra on Inflammatory parameters: • Systemic: CRP, fibrogen, feirritin, triglycerides, albumin, alfa-1-antitripsin, leukocyte counts, IL-6 levels • Cellular level: quantification and phenotyping of circulating immune cell populations; cytokine production in Peripheral Blood Mononuclear Cells (PBMCs). ;Timepoint(s) of evaluation of this end point: 4, 8 , 12 and 24 weeks after start of treatment imaging studies to assess tumor status/tumor progression every month QoL questionaires and blood donations.

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Countries

Netherlands

Contacts

Public ContactDepartment of Endocrinology

Radboud University Medical Centre

00310243614599

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026