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| ID | Type | Description | Link |
|---|---|---|---|
| 04110 | |||
| CDR0000439450 | |||
| NCI-6902 | |||
| OSU-04110 | |||
| N01CM62207 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | Given orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Histologically confirmed thyroid cancer
One of the following subtypes:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Manisha Shah | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18854394 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ECOG (Eastern Cooperative Oncology Group) performance status | Number | participants |
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| Site of metastasis | Number | participants |
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| Previous therapies | Number | number of |
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| Pathology of thyroid carcinoma | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per RECIST (Response Evaluation Criteria in Solid Tumors) | Posted | Number | percentage of participants | Up to 3 years |
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NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.
AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I & Arm II | 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 | 0 | 19 | 19 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Cramping | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 3 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE version 3 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE version 3 | Systematic Assessment |
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| Arterial thrombus | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| Ataxia | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Blurry vision | Eye disorders | CTCAE version 3 | Systematic Assessment |
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| Bronchitis/pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
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| Bruising/hematoma | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| Chest pain (muscle) | General disorders | CTCAE version 3 | Systematic Assessment |
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| Chills/Sweating | General disorders | CTCAE version 3 | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE version 3 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE version 3 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Dsypnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 3 | Systematic Assessment |
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| Flatulence/Bloating | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| General Weakness | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Systematic Assessment |
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| General pain | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Herpes zoster | Investigations | CTCAE version 3 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| Memory loss | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Minor bleeding | Vascular disorders | CTCAE version 3 | Systematic Assessment |
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| Mouth sores | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Muscle cramps | Musculoskeletal and connective tissue disorders | CTCAE version 3 | Systematic Assessment |
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| Nail changes | Skin and subcutaneous tissue disorders | CTCAE version 3 | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Paresthesias | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3 | Systematic Assessment |
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| Taste changes | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE version 3 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
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| Neutropenia | Investigations | CTCAE version 3 | Systematic Assessment |
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| Lymphopenia | Investigations | CTCAE version 3 | Systematic Assessment |
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| Thrombocytopenia | Injury, poisoning and procedural complications | CTCAE version 3 | Systematic Assessment |
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| High PTT | Investigations | CTCAE version 3 | Systematic Assessment |
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| High P/INR | Investigations | CTCAE version 3 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 3 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manisha Shah, MD | The Ohio State University Comprehensive Cancer Center | 614-293-8629 | manisha.shah@osumc.edu |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000231 | Adenocarcinoma, Papillary |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| 1(restricted in physically strenuous activity) |
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| Lymph nodes |
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| Bones |
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| Brain |
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| 1-2 sites |
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| More than 2 sites |
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| Iodin-131 |
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| External beam radiation |
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| Cytotoxic chemotherapy |
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| Follicular variant of PTC |
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| FTC |
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| Hurthle cell |
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| MTC |
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| Stable disease |
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