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

  • End date
    May 12, 2023
  • participants needed
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 4 October 2022


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.

Condition Metastatic Thyroid Cancer
Treatment cyclophosphamide, Sirolimus
Clinical Study IdentifierNCT03099356
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on4 October 2022


Yes No Not Sure

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
I 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
I 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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