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

NCT02516774 | Withdrawn Phase 1

• 2 other identifiers: 2014-002618-222014/2142
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that the particular richness of ATC's microenvironment in TAMs creates a unique opportunity for using Tumor Necrosis Factor blockade during chemotherapy and radiotherapy in order to counteract tumor resistance to therapy.

Conditions

Anaplastic Thyroid Cancers

Outcome Measures

Primary Outcomes (1)

• Recommended dose

  Two dose levels will be investigated : * Level 1: 20 mg at D1W1, D1W3, D1W5, D1W7 and D1W9. * Level 2: 40 mg at D1W1, D1W3, D1W5, D1W7 and D1W9.

  Up to 9 weeks

Study Arms (1)

Dose escalation

EXPERIMENTAL

Adalimumab will be administrated subcutaneously 1h prior to chemotherapy at D1W1, D1W3, D1W5, D1W7, and D1W9, starting with the chemotherapy for a total duration of 9 weeks (5 injections in total)

Drug: Adalimumab

Interventions

Adalimumab DRUG

Also known as: Humira®

Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven anaplastic thyroid cancers (localized or metastatic)
• Life-expectancy \> 12 weeks
• No previous treatment for anaplastic thyroid cancer excepted surgery or crizotinib
• Written Informed consent signed
• Age \> 18 years
• WHO 0-3
• Neutrophil count \> 1500 /mm3, Haemoglobin \> 9 gr/dL, Platelet count \> 100,000/mm3
• Bilirubin \< 1.5 mg/dL, Transaminases \< 3 N in absence of liver metastases or \<5 N if presence of liver metastases, PT \> 70%
• Creatinine clearance \> 50ml/mn (calculated by the MDRD formula)
• Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization). Both men and women (of childbearing potential) who are sexually active, must use adequate contraception, during and for at least 6 months post-treatment.
• Evaluable disease \> 1 cm within the cervico-mediastinal field of radiotherapy according to the Response Evaluation Criteria in Solid Tumors 1.1 criteria
• Patient affiliated to social security regimen or beneficiary of such regimen

You may not qualify if:

• Prior treatment with anthracyclines
• Left Ventricular Ejection Fraction (LVEF) \< 50%
• Known allergy to Adalimumab, doxorubicin, cisplatin, carboplatin or paclitaxel
• Chronic or acute infection \< 15 days
• Pregnant or breastfeeding patients
• Any other malignancy in the past 5 years except basal cell carcinoma and carcinoma in situ of the cervix
• Previous and/or active demyelinating disease, such as multiple sclerosis
• Prior radiotherapy to the neck
• Concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis)
• Chronic (\> 3 months) treatment with oral corticosteroids or another immunosuppressant within 15 days prior registration
• Patients with an active bleeding diathesis or taking an oral vitamin K antagonist (except low-dose Coumadin (warfarin sodium))
• 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)
• Patient already enrolled in another therapeutic trial involving an investigational substance, and when such a substance has been taken during the previous 4 weeks
• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: August 6, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

FR (1)