NCI/CTEP# 8317: Phase II trial of cediranib alone or cediranib and lenalidomide in iodine 131-refractory differentiated thyroid cancer

Print this page

NCI/CTEP# 8317: Phase II trial of cediranib alone or cediranib and lenalidomide in iodine 131-refractory differentiated thyroid cancer

Phase I Primary Objective: to determine the MTD of cediranib plus lenalidomide. Secondary objectives: (1) determine the response rate of cediranib in combination with lenalinomide in patients with iodine refractory, unresectable DTC who have evidence of disease progression within 12 months of study enrollment. (2) determine the toxicity, duration of response, progression free survival, and overall survival in patients with DTC treated with cediranib plus lenalidomide.
Phase II Primary Objectives: (1) determine the progression-free survival rates of single agent cediranib in patients with iodine refractory, unresectable differentiated thyroid cancer (DTC) who have evidence of disease progression within 12 months of study enrollment. (2) determine the progression-free survival rates of cediranib in combination with lenalinomide in patients with iodine refractory, unresectable DTC who have evidence of disease progression within 12 months of study enrollment. (3) compare the progression-free survival curves of single agent cediranib to combination therapy with cediranib with lenalinomide.
Secondary Objectives: (1) determine the response rates and duration of response, early tumor size changes, the toxicity, and overall survival in patients with DTC treated with cediranib or cediranib plus lenalidomide. (2) determine whether the presence of B-RAF or K-RAS mutations in patients with DTC predict response to cediranib or cediranib plus lenalidomide.

Protocol Number031301
Principal InvestigatorJoseph Aisner
PhasePhase I/II
ScopeNational
Applicable Disease SitesThyroid
Therapies InvolvedChemotherapy single agent systemic
Chemotherapy multiple agents systemic
Drugs InvolvedAZD2171
LENALIDOMIDE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.