Study on Cyclophosphamide and Sirolimus for Treating Advanced Thyroid Cancer Resistant to Radioactive Iodine

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03099356

Provider View

This clinical trial is exploring a new treatment using Cyclophosphamide and Sirolimus for patients with advanced thyroid cancer that has spread and does not respond to radioactive iodine therapy. The study aims to assess the safety and effectiveness of this treatment combination.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced thyroid cancer that has spread and does not respond to standard radioactive iodine therapy. The treatment involves taking two medications, Cyclophosphamide and Sirolimus, over a 28-day cycle. Patients will take Sirolimus daily for 28 days and Cyclophosphamide for 10 days within the cycle. The study will monitor patients closely for any side effects and use imaging tests every two cycles to check if the treatment is working.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of differentiated thyroid cancer that cannot be cured or have chosen not to pursue curative treatment.
  • Have measurable cancer that is growing, as shown by specific medical criteria.
  • Have previously tried radioactive iodine therapy without success or are not suitable for it.
  • Be 18 years or older.
  • Be in relatively good health, with a performance status score between 0 and 2.
  • Have a life expectancy of at least 12 weeks.
  • Have not received radioactive iodine therapy within the last 24 weeks (or 4 weeks if a post-treatment scan was negative).
  • Have adequate organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Be willing to sign an informed consent form and comply with study requirements, including taking medication and attending scheduled visits.

Exclusion Criteria

  • Cannot obtain specific genetic testing on previous tumor samples.
  • Have received chemotherapy, certain cancer drugs, or radiation therapy within the last 4 weeks.
  • Have participated in another experimental treatment within the last 4 weeks.
  • Have had radioactive iodine therapy within the last 24 weeks (or 4 weeks if a post-treatment scan was negative).
  • Have previously been treated with an mTOR inhibitor.
  • Are taking medications that affect how Cyclophosphamide and Sirolimus work and cannot stop them at least one week before starting the study.
  • Have digestive issues that affect medication absorption, such as severe nausea, vomiting, or diarrhea.
  • Have a serious uncontrolled medical condition or active infection.
  • Have allergies to Cyclophosphamide or Sirolimus.
  • Have urinary blockage issues.
  • Have dementia or mental health issues that prevent understanding the study or following its requirements.
  • Are not willing or able to use effective birth control or practice abstinence.
  • Are pregnant or breastfeeding.
  • Are currently in prison.

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