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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00134043
Other study ID # NCI-2012-01468
Secondary ID 04110CDR00004394
Status Completed
Phase Phase 2
First received August 22, 2005
Last updated July 23, 2014
Start date December 2005
Est. completion date March 2009

Study information

Verified date July 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
vorinostat
Given orally

Locations

Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 3 years No
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