Reinducing radioiodine-sensitivity in radioiodine-refractory thyroid cancer using lenvatinib

Completed

• Conditions: Radioiodine-refractory thyroid cancer; radioiodine-resistant thyroid cancer; 10014713

• Registration Number: NL-OMON55301
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-17
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Age >= 18 years at the time of informed consent
• Histologically or cytologically confirmed DTC (including papillary,
follicular or Hürthle Cell carcinoma)
• Progressive (biochemical or anatomic) disease for which lenvatinib is started
as standard treatment at the discretion of the treating physician.
• Measurable disease at baseline imaging (F-18 FDG PET) according to the
definition of the Positron Emission Tomography Response Criteria in Solid
Tumors (PERCIST) 1.0 with at least one lesion >=1.0 cm in the longest diameter
for a non-lymph node or >=1.5 cm in the short axis for a lymph node.
• RAI-R disease on structural imaging, defined as any one of the following:
o Metastatic lesions that are not RAI-avid on a diagnostic or intra-therapeutic
RAI scan performed prior to enrolment in the current study
o RAI-avid metastatic lesions which remained stable in size or progressed
according to RECIST 1.1 criteria despite RAI treatment. Absence of response is
observed during 6-9 months after high dose I-131 therapy.
• No recent treatment for thyroid cancer:
o No prior I-131 therapy is allowed <6 months prior to initiation of therapy on
this protocol (a diagnostic study using <400 MBq of I-131 is not considered
131I therapy)
o No external beam radiation therapy is allowed <4 weeks prior to initiation of
therapy on this protocol. (Previous treatment with radiation for any indication
is allowed if the investigator judges that the previous radiation does not
significantly compromise patient safety on this protocol)
• Eastern Cooperative Oncology Group (ECOG) performance status <=2 (or Karnofsky
>=60%)
• Life expectancy >=3 months
• Ability to swallow and retain orally-administered medication and no
clinically significant gastrointestinal abnormalities that may alter absorption
• Creatinine <=1.5 mg/dL (<=133 µmol/L) or estimated glomerular filtration rate
(eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
formula) >=50 mL/min/1.73m2 or 24-hour urine creatinine clearance >=50
mL/min/1.73m2
• Adequate blood coagulation function as evidenced by an international
normalized ratio (INR) <=1.5
• Adequate bone marrow function with:
o Absolute neutrophil count >=1.5 * 10^9/L
o Hemoglobin >=9 g/dL (5.6 mmol/L)
o Platelets >=100 *10^9/L
• Adequate liver function with
o Albumin >=25 g/L
o Total bilirubin <1.5x institutional upper limit of normal (ULN) with an
exception for patients with Gilbert*s syndrome
o Aspartate aminotransferase and alanine aminotransferase <=3x institutional ULN
(<=5x ULN if subject has liver metastases)
• Negative pregnancy test within 7 days prior to starting the study for
premenopausal women. Women can be included without pregnancy test if they are
either surgically sterile or have been post-menopausal for >=1 year.
• Sexually active women of childbearing potential must agree to use a highly
effective method of contraception during the study and for at least 6 months
after the last study treatment administration. Sexually active males patients
must agree to use condom during the study and for at least 6 months after the
last study treatment administration. Also, it is recommended their women of
childbearing pot

Exclusion Criteria

• Concomitant or previous malignancies within the last 3 years. Patients are
eligible for this study if they have been disease-free of the previous
malignancy for at least 3 years, have a history of completely resected
non-melanoma skin cancer and/or have indolent secondary malignancies.
• Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
compression
• Evidence of cardiovascular risk including any of the following:
o Clinically relevant arrhythmias
o Acute coronary syndromes, severe/unstable angina
o Symptomatic congestive heart failure
• Use of other investigational drugs within 28 days preceding the first dose of
treatment in this study or during the study
• Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy
to drugs chemically related to lenvatinib and/or to Thyrotropin alfa (human
recombinant thyrotropin)
or other known contents of the two drugs.
• Inability to follow a low iodine diet or requiring medication with high
content in iodide (e.g. amiodarone)
• Patients who received iodinated intravenous contrast as part of a
radiographic procedure within 6-8 weeks of study registration. Patients are
eligible for this study if urinary iodine analysis reveals that the excess
iodine has been adequately cleared after the last intravenous contrast
administration
• Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection or psychiatric illness/social situations that would limit
compliance with study requirements.
• Pregnant, lactating or breast feeding women
• Any medical or other condition that in the opinion of the investigator(s)
would preclude the participation in a clinical study
• Unwillingness or inability to comply with study and follow-up procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified