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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00134043 |
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 |
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Head and Neck Cancer |
Drug: vorinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Histone Deacetylase Inhibitor SAHA in Patients With Metastatic Thyroid Carcinoma |
Estimated Enrollment: | 25 |
Study Start Date: | December 2005 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed thyroid cancer
One of the following subtypes:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000439450, OSU-04110, NCI-6902 |
Study First Received: | August 22, 2005 |
Last Updated: | March 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00134043 History of Changes |
Health Authority: | United States: Federal Government |
stage IV follicular thyroid cancer stage II follicular thyroid cancer stage IV papillary thyroid cancer stage II papillary thyroid cancer |
thyroid gland medullary carcinoma insular thyroid cancer recurrent thyroid cancer |
Anticarcinogenic Agents Anti-Inflammatory Agents Adenocarcinoma, Follicular Carcinoma, Medullary Thyroid Neoplasms Thyroid Cancer, Papillary Vorinostat Thyroid Cancer, Medullary Endocrine System Diseases Recurrence Carcinoma |
Analgesics, Non-Narcotic Thyroid Cancer, Follicular Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Endocrinopathy Antirheumatic Agents Thyroid Diseases Endocrine Gland Neoplasms |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Physiological Effects of Drugs Vorinostat Endocrine System Diseases Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Thyroid Diseases Endocrine Gland Neoplasms |