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Cyclophosphamide and Sirolimus for Metastatic Thyroid Cancer

This study is testing two drugs, Cyclophosphamide and Sirolimus, for people with metastatic differentiated thyroid cancer that hasn't responded to radioactive iodine (RAI-refractory). You might be able to join if your cancer has spread, can't be cured with standard treatments, and has shown recent growth. The study aims to see how many patients respond to this treatment combination. You would take Cyclophosphamide for 5 days, twice a month, and Sirolimus daily for 28 days, which makes one treatment cycle. Doctors will watch you closely for side effects and check how well the treatment is working with imaging scans.

Study design
This is a pilot study, meaning it's a small, early-stage trial, and it's not randomized. It plans to enroll 22 participants.
What's involved
You would take two medications by mouth: Cyclophosphamide for 5 days twice a month, and Sirolimus daily for 28 days. You will have imaging scans every two cycles to check the treatment's effectiveness.
Compensation
Not stated in the trial record.
Follow-up
Patients will be followed for response until their cancer progresses or for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03099356

Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~22 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:CyclophosphamideSirolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients that respond to treatment
Measured over Patients will be followed for response until progression or up to 2 Years

Conditions

Metastatic Thyroid Cancer

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Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Paul Swiecicki, M.D. · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Measurable disease (\>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation.
Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician.
Age ≥ 18 years
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Life expectance of ≥ 12 weeks
131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)
Adequate organ and marrow function
Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment
Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures

Exclusion

Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing
Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks
Prior experimental therapy within 4 weeks of planned start of this trial
131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
Previous treatment with an mTOR inhibitor
Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least one week prior to the start of treatment with Cyclophosphamide and Sirolimus
Impairment of GI (gastrointestinal) function or GI disease that may significantly alter the absorption of study medications (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) including dependence on a G-Tube for administration of medications.
A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
Patients with known sensitivities to either cyclophosphamide and/or sirolimus
Patients with known urinary outflow obstruction
Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
Women who are pregnant or breast-feeding
Patients residing in prison

What this trial measures

  • Percentage of patients that respond to treatmentPatients 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.