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Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer - Article


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Gamma-Linolenic Acid

GLA




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

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
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

Further Study Details: 

OBJECTIVES:

Primary

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 above,  Genders Eligible for Study:  Both
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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00134043


Study chairs or principal investigators

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

Study ID Numbers:  CDR0000439450; OSU-04110; NCI-6902
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

Resources



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January 9, 2009



Page Updated: May 11, 2006
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