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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00134043
First received: August 22, 2005
Last updated: June 3, 2013
Last verified: June 2013

August 22, 2005
June 3, 2013
December 2005
March 2009   (final data collection date for primary outcome measure)
Objective response rate (PR + CR) using RECIST/WHO response criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00134043 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma

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 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.

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.

SECONDARY OBJECTIVES:

I. 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Insular Thyroid Cancer
  • Recurrent Thyroid Cancer
  • Stage II Follicular Thyroid Cancer
  • Stage II Papillary Thyroid Cancer
  • Stage IV Follicular Thyroid Cancer
  • Stage IV Papillary Thyroid Cancer
  • Thyroid Gland Medullary Carcinoma
Drug: vorinostat
Given orally
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza
Experimental: Arm I
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.
Intervention: Drug: vorinostat
Woyach JA, Kloos RT, Ringel MD, Arbogast D, Collamore M, Zwiebel JA, Grever M, Villalona-Calero M, Shah MH. Lack of therapeutic effect of the Histone Deacetylase Inhibitor Vorinostat in Patients with Metastatic Radioiodine-Refractory Thyroid Carcinoma. J Clin Endocrinol Metab. 2008 Oct 14; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00134043
NCI-2012-01468, 04110, CDR0000439450, NCI-6902, OSU-04110, N01CM62207
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Manisha Shah Ohio State University
National Cancer Institute (NCI)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP