An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
University of Michigan Rogel Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCyclophosphamide
Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
- DrugSirolimus
Sirolimus 4 mg, PO, days 1-28
Location
- University of Michigan Cancer CenterAnn Arbor, Michigan