Trial Evaluating Gleevec in Patients With Anaplastic Thyroid Carcinoma
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Imatinib
Intervention description: Imatinib 400 mg capsules were administered twice daily with food for 4 week cycles.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anaplastic Thyroid Cancer

Summary:

      Anaplastic thyroid cancers are rare, aggressive tumors. Standard treatment options include
      surgery and chemoradiation. Few treatment options are available once metastases develop.
      Recent data suggest that Imatinib (Gleevec) may be advantageous in this patient population.
      Patients who have been treated for anaplastic thyroid cancer with chemoradiation or surgery
      who develop recurrent or metastatic disease outside of the field of radiation are eligible.
      Patients will be treated with Imatinib 400 mg two times a day for eight weeks, followed by
      radiologic assessment. Patients will be treated until disease progression or a complete
      response is obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically confirmed anaplastic thyroid carcinoma, who have
             measurable disease.

          -  Patients with brain metastases are eligible if they have been stable for at least six
             weeks post-radiation therapy.

          -  Age 18 years, male or female.

          -  Karnofsky performance status (KPS) of > 70%.

          -  Life expectancy of at least 12 weeks.

          -  Hematologic: ANC 1,500 mm3, hemoglobin 8.0 g/dl, platelets 100,000/mm3

          -  Normal serum calcium level within normal limits for the institution documented within
             14 days prior to registration.

          -  All patients (including those with liver metastases) must have adequate hepatic
             function as defined by a serum bilirubin 1.5 x the institutional upper limit of normal
             (ULN), and ALT and AST <2.5 x ULN, obtained within 14 days prior to registration.

          -  Patients must have a serum creatinine less than 1.5 x the institutional upper limits
             of normal (adjusted for age) within 14 days of registration.

          -  Women of childbearing potential must have a negative pregnancy test at baseline, prior
             to receiving any study drug. (Pregnant or lactating patients are excluded.)

          -  Patients of reproductive potential must practice effective contraception while on
             study and for at least six months after receiving the last dose of study drug.

          -  All patients must sign an informed consent prior to enrollment.

          -  No prior history of non-thyroid malignancy, except adequately treated skin cancer or
             in situ cervical carcinoma or any other cancer in complete remission for at least two
             years.

          -  Prior chemotherapy, chemoradiation, radiation therapy, or surgery must have been
             completed at least 28 days prior to registration, and all toxicities must have
             resolved. Patients who have been treated with nitrosourea or mitomycin C must be off
             of these drugs for at least 6 weeks prior to registration.

          -  Patients must be able to take oral medications.

        Exclusion Criteria:

          -  Anaplastic thyroid cancer that does not overexpress PDGF receptors or c-Abl by
             immunohistochemistry

          -  Any medical or psychiatric illness which, in the opinion of the principal
             investigator, would compromise the patient's ability to tolerate this treatment
             regimen.

          -  No concurrent radiotherapy (to the primary tumor) or chemotherapy may be given to the
             patient during the administration of the study drug.

          -  Pregnant or lactating women, women of childbearing potential with either a positive
             pregnancy test (PPT) at baseline, or sexually active females not using reliable
             contraceptive methods while on study and for at least six months after chemotherapy.
             (Postmenopausal women must have been amenorrheic for least 12 months to be considered
             of non-childbearing potential).

          -  Sexually active males not using reliable contraceptive methods while on the study and
             for at least six months after chemotherapy.

          -  Patients with malabsorption syndromes will be excluded.

          -  Serious concurrent infections.

          -  Patients who have had previous organ allografts will be excluded.

          -  Prisoners.

          -  Patients with chronic liver disease (i.e chronic active hepatitis and cirrhosis).

          -  Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.

          -  Patients who have had major surgery within 2 weeks of study entry.

          -  Patients with grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria (i.e. congestive heart failure, myocardial infarction within 6
             months of study entry).