Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Condition: Insular Thyroid Cancer; Recurrent Thyroid Cancer; Stage II Follicular Thyroid Cancer; Stage II Papillary Thyroid Cancer; Stage IV Follicular Thyroid Cancer; Stage IV Papillary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Diseases
Intervention: Bortezomib
Intervention description: Administered IV at the dose of 1.3 mg/m^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: National Thyroid Cancer Treatment Cooperative Study Group; NTCTCSG; bortezomib; velcade; metastatic differentiated thyroid carcinoma; Differentiated thyroid carcinoma; follicular epithelial thyroid cells; papillary; oxyphilic cell; Hurthle cell; insular cell; columnar cell; tall cell

Summary:

      This phase II trial is studying how well bortezomib works in treating patients with
      metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%

          -  Platelet count >= 100,000/mm^3

          -  Absolute neutrophil count >= 1,500/mm^3

          -  White Blood Count (WBC) >= 3,000/mm^3

          -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 times upper
             limit of normal

          -  Bilirubin normal

          -  No symptomatic congestive heart failure

          -  Creatinine normal OR creatinine clearance >= 60 mL/min

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except basal cell skin cancer or carcinoma
             in situ of the cervix

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled illness

          -  At least 4 weeks since prior chemotherapy

          -  No more than 2 prior chemotherapy regimens

          -  At least 6 months since prior external beam radiotherapy for locoregional disease in
             the thyroid bed or to the cervical or upper mediastinal lymph nodes (dose =< 6,000
             cGy)

          -  At least 6 months since prior radioiodine therapy

          -  No prior external radiotherapy to the measured tumor

          -  Prior thyroidectomy allowed

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  Unresponsive to prior radioiodine therapy

          -  Histologically confirmed differentiated thyroid cancer-papillary or follicular type,
             including, but not limited to, any of the following variants: hurthle cell
             (oxyphilic), insular, columnar cell, tall cell

          -  Metastatic disease

          -  At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR
             >= 10 mm by spiral CT scan

          -  No prior radiotherapy to the only measurable lesion

          -  No radioiodine uptake in the measured metastatic tumor by radioiodine scan (Note: Must
             have had >= 1 radioiodine scan since the last radioiodine treatment)

          -  No known brain metastases