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Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma

Phase 2
18 Years
Not Enrolling
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

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Trial Information

Phase II Study of Histone Deacetylase Inhibitor SAHA (Vorinostat) in Patients With Metastatic Thyroid Carcinoma


I. Determine the objective response rate in patients with metastatic and/or locally advanced
or locally recurrent thyroid cancer treated with suberoylanilide hydroxamic acid.


I. Determine the toxicity of this drug in these patients.


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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate (PR + CR) using RECIST/WHO response criteria

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Manisha Shah

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular
  • Carcinoma, Medullary



Ohio State University Medical Center Columbus, Ohio  43210