This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
Sirolimus 4 mg, PO, days 1-28
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGPercentage of patients that respond to treatment
The primary measure of efficacy will be the overall response rate (ORR) which is defined as those achieving either complete response (CR) or partial response (PR). Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete response is defined as Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart (there can be no appearance of new lesions) and the disappearance of all non-target lesions and normalization of tumor marker level.
Time frame: Patients will be followed for response until progression or up to 2 Years
The number of patients that experience toxicity
The number of patients that experience toxicity by type will be reported.
Time frame: Patients are followed for toxicity up to 30 days after the last dose of study drug
Median overall survival time
The median duration of time from start of treatment until death
Time frame: Patients will be followed until death or up to 2 years
Median progression free survival time
The median duration of time from start of treatment until progression. Progression is defined as at least a 20% increase in the sum of the LD (longest diameter) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Patients will be followed for response until progression or up to 2 Years
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