Actively Recruiting
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
Led by University of Michigan Rogel Cancer Center · Updated on 2025-08-01
22
Participants Needed
1
Research Sites
500 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed differentiated thyroid cancer with or without metastases, not suitable for curative treatment or patient refusal of curative treatment
- Measurable disease larger than 10 mm with documented progression based on RECIST criteria
- Previous failure of Iodine-131 therapy or not candidates for Iodine-131 as assessed by physician
- Age 18 years or older
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- No Iodine-131 therapy within 24 weeks prior to entry (4 weeks if negative post-treatment scan)
- Adequate organ and bone marrow function
- Women of childbearing potential must have a negative pregnancy test within 3 days before treatment
- Signed informed consent prior to enrollment
- Willingness and ability to follow scheduled visits, treatment plans, and study procedures
You will not qualify if you...
- Unable to obtain Foundation One testing on archival tissue or no prior Next Generation Sequencing
- Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks prior to study
- Prior experimental therapy within 4 weeks before trial start
- Iodine-131 therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
- Previous treatment with any mTOR inhibitor
- Current use of strong CYP3A4 or P-glycoprotein inhibitors or inducers that cannot be stopped at least one week before treatment
- Significant gastrointestinal problems affecting medication absorption or dependence on G-Tube for medication
- Serious uncontrolled medical disorder or active infection impairing treatment ability
- Known allergies to cyclophosphamide or sirolimus
- Known urinary outflow obstruction
- Dementia or mental status impairing informed consent or compliance
- Patients with procreative potential unwilling or unable to use effective contraception or abstinence
- Pregnant or breastfeeding women
- Patients residing in prison
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
P
Paul Swiecicki, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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