RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: RAD001
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radioiodine refractory thyroid cancer; RAD001

Summary:

      Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very
      limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial
      seeks to expand treatment options for this disease with a new, oral drug called RAD001. It is
      an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the
      gastrointestinal tract and has been approved for the treatment of metastatic renal cell
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed locally advanced or metastatic thyroid cancer, excluding
             thyroid lymphomas not amenable to or refractory to surgical resection, external beam
             radiotherapy, radioiodine or other local therapies.

          -  Prior therapy with chemotherapy and targeted therapies except for mTor inhibitors is
             allowed.

          -  Medullary thyroid cancer with documented evidence of disease progression by modified
             RECIST within 6 months before study day 1 or symptomatic disease at the time of
             screening in the absence of documented disease progression.

          -  Differentiated thyroid cancer with documented evidence of disease progression by
             modified RECIST within 6 months before study day 1.

          -  Anaplastic thyroid cancer with disease progression with documented disease progression
             by modified RECIST within 6 months of study day 1.

          -  Patients must have at least one measurable site of disease according to RECIST
             criteria that has not previously irradiated. If the patient has has previous radiation
             to the marker lesion(s), there must be evidence of progression since radiation.

          -  18 years of age or older

          -  WHO performance status 2 or less

          -  Adequate bone marrow, liver, and renal function

          -  Fasting serum cholesterol 300mg/dL or less OR 7.75 mmol/L or less AND fasting
             triglycerides 2.5x ULN or less

        Exclusion Criteria:

          -  Patients receiving anticancer therapies within last 2 weeks or who have received
             radiation therapy within 3 weeks of study day 1

          -  Prior therapy with mTOR inhibitors

          -  Patients who have had a major surgery or significant traumatic injury within 4 weeks
             of start of study drug, patients who have not recovered from the side effects of any
             major surgery or patients that may require major surgery during the course of the
             study

          -  Prior treatment with any investigational drug within the preceding 3 weeks

          -  Patients receiving chronic, systemic treatment with corticosteroids or another
             immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

          -  Patients should not receive immunization with attenuated live vaccines within 2 weeks
             of study entry or during study period

          -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases

          -  Other malignancies within the past 3 years except for adequately treated carcinoma of
             the cervix or basal or squamous cell carcinomas of the skin

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study

          -  A known history of HIV seropositivity

          -  Impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of RAD001

          -  Patients with an active, bleeding diathesis

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods

          -  Patients who have received prior treatment wih an mTOR inhibitor

          -  Patients with a known hypersensitivity to RAD001 or other rapamycins or to its
             excipients

          -  History of noncompliance to medical regimens