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Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
This study has been completed.
First Received: August 22, 2005   Last Updated: March 7, 2009   History of Changes
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00134043
  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
Head and Neck Cancer
Drug: vorinostat
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer
Drug Information available for: Suberoylanilide hydroxamic acid Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Histone Deacetylase Inhibitor SAHA in Patients With Metastatic Thyroid Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: December 2005
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134043

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Study Chair: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009