REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas
Condition: Thyroid Neoplasms
MeSH terms: Carcinoma; Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Diseases
Intervention: Lenalidomide
Intervention description: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lenalidomide; Clinical Trials phase II; Carcinomas, thyroid; Radioiodine-Unresponsive; Papillary; Follicular

Summary:

      The primary objective of the study is to assess the anti-tumor activity of REVLIMID®
      (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid
      carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and
      response duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of follicular, papillary, insular, or Hürthle-cell thyroid
             carcinoma. Histologic slides and/or tissue blocks must be reviewed at the University
             of Kentucky Medical Center.

          -  Patients must have an unresectable, distantly metastatic tumor, which does not
             concentrate radioactive iodine. Alternatively, follicular or papillary thyroid
             carcinoma patients with large distant tumor burdens which have not sufficiently
             responded to more than 800 mCi I-131 cumulative therapy and are progressive (criteria
             #4) may be appropriate for inclusion.

          -  No systemic chemotherapy agents within 4 weeks of initiation of therapy.

          -  Patients must have 3 consecutive radiographic evaluations demonstrating a cumulative
             30% increase in tumor volume over a period of one year or less.

          -  Patients must be over the age of 18 years with the ability to understand and willing
             to sign an informed consent.

          -  Non-pregnant (if female). Women of childbearing potential (fertile females) must have
             a negative serum or urine pregnancy test within one day of starting study drug. In
             addition, sexually active fertile female subjects must agree to adequate contraceptive
             methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation,
             intrauterine device, barrier contraceptive with spermicide; or vasectomized partner)
             while on study drug. Men must agree to use latex condoms when having sex with fertile
             women.

          -  Karnofsky performance status ≥ 70.

          -  Baseline laboratory studies:

               -  absolute neutrophil count (ANC) > 1000/mm3

               -  platelet count ≥ 100 K/mm3

               -  creatinine ≤ 1.5 mg/dL, and

               -  transaminase levels (AST/SGOT, ALT/SGPT) ≤ 2 x upper limit of normal (ULN) (or ≤
                  5 x I:M if hepatic metastases are present)

          -  Disease free of other prior malignancies for ≥ 5 years, with the exception of
             currently treated basal cell/squamous cell carcinoma of the skin or "in-situ"
             carcinoma of the cervix or breast.

          -  Thyroid stimulating hormone (TSH, thyrotropin) levels must be suppressed with
             sufficient levothyroxine to be kept beneath the normal range of the assay.

        Exclusion Criteria:

          -  Patients may not have had prior REVLIMID® therapy.

          -  No serious concomitant medical or psychiatric illness that might interfere with
             informed consent or conduct of the study, including active infections that are not
             controlled with medication.

          -  Patients must not be pregnant or breastfeeding.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum, characterized by a desquamating rash, while
             taking thalidomide or similar drugs.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Concurrent use of other anti-cancer agents or treatments, with the exception of
             thyrotropin-suppression by levothyroxine.

          -  All subjects with central nervous system involvement, with the exception of those
             subjects whose central nervous system metastases have been treated with either
             radiotherapy and/or surgery and remain asymptomatic with no evidence of active central
             nervous system disease (verified by computed tomography [CT] scan or magnetic
             resonance imaging [MRI]) for at least 6 months.

          -  Known to be positive for HIV or infectious hepatitis, type A, B, or C.

          -  Patients with medullary or anaplastic thyroid carcinomas are excluded. Patients whose
             disease is limited to bone metastases are excluded.