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

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Study ID: NCT02516774
Phase: PHASE1
Status: Withdrawn

Conditions

Anaplastic Thyroid Cancers

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Adalimumab — DRUG

Study Details

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.

Key Dates

Start date: Dec 31, 2014
Status verified: Jan 2016
Primary completion: Dec 31, 2015
Completion: Dec 31, 2015

Study Design

Enrollment: 0 participants (actual)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Dose escalation
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)

Primary Outcome Measure

Recommended dose [ Time Frame: Up to 9 weeks ]