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Clinical Trial: Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) August 2005
Purpose
RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
| follicular thyroid cancer insular thyroid cancer medullary thyroid cancer papillary thyroid cancer Thyroid Cancer | Drug: suberoylanilide hydroxamic acid Procedure: chemotherapy Procedure: enzyme inhibitor therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Thyroid Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Suberoylanilide Hydroxamic Acid in Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic and/or locally advanced or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.
Secondary
- 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.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 4-7 months.
Eligibility
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 6 months
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- 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
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior external beam radiotherapy
- At least 24 weeks since prior radioactive iodine I^131 therapy
Surgery
- Not specified
Other
- 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
Location and Contact Information
Manisha H. Shah, MD, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: August 23, 2005
Record first received: August 22, 2005
ClinicalTrials.gov Identifier: NCT00134043
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30

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