Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

PRIMARY OBJECTIVE:

I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.

SECONDARY OBJECTIVE:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

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