Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer
About this trial
This is an interventional treatment trial for Insular Thyroid Cancer
Eligibility Criteria
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
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Arm I
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.