Status:
COMPLETED
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Insular Thyroid Cancer
Recurrent Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with metastatic and/or locally advanced or locally recurrent thyroid cancer. Drugs used in chemother...
Detailed Description
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. SEC...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00134043
Start Date
December 1 2005
End Date
March 1 2009
Last Update
August 11 2014
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210