Can a Two-Drug combo shrink Hard-to-Treat thyroid tumors?
NCT ID NCT03099356
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This phase II trial is testing whether two drugs, cyclophosphamide and sirolimus, can help people with metastatic thyroid cancer that has stopped responding to radioactive iodine treatment. Participants take both drugs in monthly cycles, and doctors monitor tumor size and side effects. The goal is to see if the combination can shrink or control the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclophosphamide and sirolimus
- What this could lead to
- If effective, this combination could offer a new treatment option for people with advanced thyroid cancer that no longer responds to standard radioactive iodine therapy.
- What could go wrong
- This is a small, early-phase trial, so the treatment may not work for everyone and could cause side effects like toxicity. More research would be needed before it becomes a standard therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan Cancer Center
RECRUITINGAnn Arbor, Michigan, 48109, United States
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