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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03099356
Phase
PHASE2
Status
Recruiting

Conditions

  • Metastatic Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
  • Sirolimus — DRUG
    Sirolimus 4 mg, PO, days 1-28

Study Details

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.

Key Dates

Start date
Apr 27, 2017
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cyclophosphamide and Sirolimus
    Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19

Primary Outcome Measure

Percentage of patients that respond to treatment [ Time Frame: Patients will be followed for response until progression or up to 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Cancer CenterAnn ArborMichigan48109
Paul Swiecicki, M.D.
Francis Worden, M.D.
734-936-0453
Paul Swieciki, M.D. (PRINCIPAL_INVESTIGATOR)

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