NCT03099356

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
DRUG	Sirolimus	Sirolimus 4 mg, PO, days 1-28

Timeline

• Start date: 2017-04-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-04-04
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study