A Trial of Adalimumab Combined to Chemotherapy and Radiotherapy in Patients With Anaplastic Thyroid Cancers

Exclusion Criteria

• •1. Prior treatment with anthracyclines
• •2. Left Ventricular Ejection Fraction (LVEF) \< 50%
• •3. Known allergy to Adalimumab, doxorubicin, cisplatin, carboplatin or paclitaxel
• •4. Chronic or acute infection \< 15 days
• •5. Pregnant or breastfeeding patients
• •6. Any other malignancy in the past 5 years except basal cell carcinoma and carcinoma in situ of the cervix
• •7. Previous and/or active demyelinating disease, such as multiple sclerosis
• •8. Prior radiotherapy to the neck
• •9. Concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis)
• •10. Chronic (\> 3 months) treatment with oral corticosteroids or another immunosuppressant within 15 days prior registration
• •11. Patients with an active bleeding diathesis or taking an oral vitamin K antagonist (except low-dose Coumadin (warfarin sodium))
• •12. Other concurrent severe and/or uncontrolled disease which could compromise participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmia, active ischemic heart disease, myocardial infarction during the previous six months, chronic liver or renal disease, active upper GI tract ulceration)
• •13. Patient already enrolled in another therapeutic trial involving an investigational substance, and when such a substance has been taken during the previous 4 weeks
• •14. Chronic Hepatitis B virus and previous viral hepatitis with risk of reactivation, Hepatitis C virus and human immunodeficiency virus 1 or human immunodeficiency virus 2 infection, active or latent tuberculosis infection
• •15. Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons Refusal or absence of biopsy (excepted for initial pathological diagnosis) will not constitute an exclusion criterion.