Using Cyclophosphamide and Sirolimus to treat advanced thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the effectiveness of Cyclophosphamide and Sirolimus in treating patients with metastatic differentiated thyroid cancer that is resistant to radioactive iodine therapy. Participants will receive Sirolimus daily for 28 days and Cyclophosphamide on specific days within a 28-day cycle. The study will closely monitor patients for toxicity and assess treatment efficacy through imaging every two cycles. The goal is to evaluate the potential of this combination therapy in a non-randomized setting.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Paul Swiecicki, M.D. — University of Michigan Rogel Cancer Center
• Study coordinator: Cancer AnswerLine
• Email: canceranswerline@umich.edu
• Phone: 1-800-865-1125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.