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

NCT ID: NCT00134043

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

Given orally

Interventions

vorinostat

Given orally

Intervention Type: DRUG

Other Intervention Names

L-001079038; SAHA; suberoylanilide hydroxamic acid; Zolinza

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Shah

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 18854394 (View on PubMed)

Other Identifiers

04110

Identifier Type: -

Identifier Source: secondary_id

CDR0000439450

Identifier Type: -

Identifier Source: secondary_id

NCI-6902

Identifier Type: -

Identifier Source: secondary_id

OSU-04110

Identifier Type: -

Identifier Source: secondary_id

N01CM62207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01468

Identifier Type: -

Identifier Source: org_study_id