Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma

Inclusion criteria

• Non-medullary thyroid carcinoma
• Having undergone total thyroidectomy and at least 1 treatment with [131]sodium iodine (NaI)
• Presence of local or metastatic disease, radiologically proven. A minimum of 1 target lesion (at least 1cm for soft tissue and 1.5cm for lymph nodes) must be present.
• Radioiodine refractory disease; at least one lesion without therapeutic relevant uptake at previous post-therapeutic scintigraphy and/or negative diagnostic [123]NaI-scan.
• The target lesion must not be eligible for local treatments.
• Hematologic lab values should be at least: absolute neutrophil count >1.4x10^9/liter, hemoglobin>5.5mmol/liter, thrombocytes >99x10^9/liter

Exclusion criteria

• Creatinine clearance <50ml/min and/or active kidney disease
• Cardiac arrhythmias
• Electrolyte disorder
• Concomitant drugs that interfere with digoxin metabolism such as P-glycoprotein inductors or inducers, including but not limited to penicillamine, sulfasalazin, tipranavir, amiodarona, diltiazem, itraconazole, ketoconazole, kinidin, lapatinib, propafenon, vemurafenib, verapamil, azithromycin, clarithromycin, erythromycin, roxithromycin, chloroquin, ciclosporin, anti hepatitis C drugs, anti-HIV drugs, hydroxychloroquine.
• Pregnancy, lactating or breast-feeding women.
• Having undergone a procedure with iodine contrast agent within the last 3 months.
• Prior therapy with radioactive iodine <6 months prior to participation.
• External beam radiation therapy <4 weeks prior to participation.
• Having undergone chemotherapy or targeted therapy <4 weeks prior to participation.
• Eastern Cooperative Oncology Group (ECOG) score >2.
• Use of other investigational drugs within 4 weeks preceding the first dose of digoxin treatment.
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to digoxin.
• Uncontrolled intercurrent illness that would limit compliance with the study requirements.
• Unwillingness or inability to comply with study and follow-up procedures.
• Other active malignancies other than basal cell carcinoma. Malignancies that have been in complete remission over 2 years are not considered active malignancies.
• Rapidly progressive disease in which urgent start with systemic therapy is required.