RecruitingPhase 2NCT03099356

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

An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

22 participants

Start Date

Apr 27, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of two drugs — cyclophosphamide (a mild chemotherapy) and sirolimus (an immune-modulating drug) — in people with a type of thyroid cancer that no longer responds to radioactive iodine treatment. **You may be eligible if...** - You have been diagnosed with differentiated thyroid cancer (a common type of thyroid cancer) - Your cancer cannot be cured with standard treatment, or you have declined curative treatment - Your cancer has measurable tumors and has been growing despite treatment - Your cancer no longer responds to radioactive iodine (I-131) therapy, or you are not a candidate for it - You are 18 years or older - You are able to do most normal daily activities - Your kidneys, liver, and blood counts are within acceptable ranges - You agree to use contraception if you could become pregnant **You may NOT be eligible if...** - Your cancer has not been tested with advanced genetic analysis (Next Generation Sequencing) - You received chemotherapy, targeted therapy, or radiation within the last 4 weeks - You have received an experimental treatment within the last 4 weeks - You have certain serious heart, lung, or other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Cyclophosphamide 100 mg, PO, days 1-5 and 15-19

DRUGSirolimus

Sirolimus 4 mg, PO, days 1-28


Locations(1)

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

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NCT03099356


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