Clinical trial NCT00115739 (phase 2, status: terminated)
Conditions: thyroid cancer
ICD codes: C73, D34, D44.0, Z85.850
Drugs: imatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Reason stopped: 
    study was closed early due to slow accrual
  
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).