Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT03099356|
Recruitment Status : Suspended (Enrollment and/or interactions/interventions temporarily paused due to COVID-19 and expected to resume in the future. This is not a suspension of IRB approval.)
First Posted : April 4, 2017
Last Update Posted : May 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Thyroid Cancer||Drug: Cyclophosphamide Drug: Sirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer|
|Actual Study Start Date :||April 27, 2017|
|Estimated Primary Completion Date :||May 12, 2022|
|Estimated Study Completion Date :||May 12, 2023|
Experimental: Cyclophosphamide and Sirolimus
Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
Sirolimus 4 mg, PO, days 1-28
- Percentage of patients that respond to treatment [ Time Frame: Patients will be followed for response until progression or up to 2 Years ]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.
- The number of patients that experience toxicity [ Time Frame: Patients are followed for toxicity up to 30 days after the last dose of study drug ]The number of patients that experience toxicity by type will be reported.
- Median overall survival time [ Time Frame: Patients will be followed until death or up to 2 years ]The median duration of time from start of treatment until death
- Median progression free survival time [ Time Frame: Patients will be followed for response until progression or up to 2 Years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099356
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Francis Worden, M.D.||University of Michigan Rogel Cancer Center|