Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer

PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with metastatic and/or locally advanced or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients.

OUTLINE:

Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA. After completion of study treatment, patients are followed within 4 weeks.

Inclusion criteria

• Histologically confirmed thyroid cancer

• One of the following subtypes:

• Papillary thyroid cancer
• Follicular thyroid cancer
• Hürthle cell thyroid cancer
• Insular thyroid cancer
• Medullary thyroid cancer
• Mixed histology thyroid cancer
• Poorly differentiated thyroid cancer
• Tall-cell thyroid cancer
• Metastatic and/or locally advanced or locally recurrent disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• Lesions in a previously irradiated area allowed provided there has been subsequent disease progression of the irradiated lesions
• The following are not considered measurable disease:

• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Lymphangitis cutis/pulmonis
• Abdominal masses not confirmed and followed by imaging techniques
• Cystic lesions
• Not a candidate for radioactive iodine I^131 therapy
• Performance status - ECOG 0-1
• At least 6 months
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine ≤ 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• No other active malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix
• More than 4 weeks since prior systemic cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No more than 2 prior chemotherapy regimens for the treatment of thyroid cancer
• See Disease Characteristics
• More than 4 weeks since prior external beam radiotherapy
• At least 24 weeks since prior radioactive iodine I^131 therapy
• Recovered from prior therapy
• More than 4 weeks since prior valproic acid or any other histone deacetylase inhibitor
• More than 4 weeks since prior investigational tumor-specific therapy
• Concurrent oral or IV bisphosphonates for bony metastases allowed at the discretion of the investigator
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent tumor-specific or investigational therapy
• No other concurrent anticancer therapy
• No concurrent adjuvant therapy for another cancer