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
Conditions
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.
Interventions
Given orally
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | Up to 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DTCs (Well-differentiated Thyroid Carcinomas) 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.
vorinostat: Given orally | 16 |
| MTC (Medullary Thyroid Cancer) 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.
vorinostat: Given orally | 3 |
| Total | 19 |
Baseline characteristics
| Characteristic | DTCs (Well-differentiated Thyroid Carcinomas) | MTC (Medullary Thyroid Cancer) | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 65 years | 64 years |
| ECOG (Eastern Cooperative Oncology Group) performance status 0 (Fully active) | 6 participants | 2 participants | 8 participants |
| ECOG (Eastern Cooperative Oncology Group) performance status 1(restricted in physically strenuous activity) | 10 participants | 1 participants | 11 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 3 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pathology of thyroid carcinoma Classic PTC | 12 participants | 0 participants | 12 participants |
| Pathology of thyroid carcinoma Follicular variant of PTC | 2 participants | 0 participants | 2 participants |
| Pathology of thyroid carcinoma FTC | 1 participants | 0 participants | 1 participants |
| Pathology of thyroid carcinoma Hurthle cell | 1 participants | 0 participants | 1 participants |
| Pathology of thyroid carcinoma MTC | 0 participants | 3 participants | 3 participants |
| Previous therapies Cytotoxic chemotherapy | 6 number of | 2 number of | 8 number of |
| Previous therapies External beam radiation | 6 number of | 2 number of | 8 number of |
| Previous therapies Iodin-131 | 16 number of | 0 number of | 16 number of |
| Previous therapies Surgery | 15 number of | 3 number of | 18 number of |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 3 Participants | 16 Participants |
| Region of Enrollment Canada | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 15 participants | 3 participants | 18 participants |
| Sex: Female, Male Female | 11 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
| Site of metastasis 1-2 sites | 13 participants | 1 participants | 14 participants |
| Site of metastasis Bones | 4 participants | 2 participants | 6 participants |
| Site of metastasis Brain | 4 participants | 0 participants | 4 participants |
| Site of metastasis Lungs | 16 participants | 0 participants | 16 participants |
| Site of metastasis Lymph nodes | 8 participants | 1 participants | 9 participants |
| Site of metastasis More than 2 sites | 3 participants | 2 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: Up to 3 years
Population: Per RECIST (Response Evaluation Criteria in Solid Tumors)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTCs (Well-differentiated Thyroid Carcinomas) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | PR (Partial Response) | 0 percentage of participants |
| DTCs (Well-differentiated Thyroid Carcinomas) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | CR (Complete Response) | 0 percentage of participants |
| DTCs (Well-differentiated Thyroid Carcinomas) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | Stable disease | 56 percentage of participants |
| MTC (Medullary Thyroid Cancer) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | PR (Partial Response) | 0 percentage of participants |
| MTC (Medullary Thyroid Cancer) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | CR (Complete Response) | 0 percentage of participants |
| MTC (Medullary Thyroid Cancer) | Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria | Stable disease | 0 percentage of participants |