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

Primary Purpose

Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vorinostat
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insular Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2005
Last Updated
July 23, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00134043
Brief Title
Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer
Official Title
Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
vorinostat
Other Intervention Name(s)
L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Shah
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18854394
Citation
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. 2009 Jan;94(1):164-70. doi: 10.1210/jc.2008-1631. Epub 2008 Oct 14.
Results Reference
derived

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

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