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

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ClinicalTrials.gov Identifier: NCT00134043
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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
Intervention Drug: vorinostat
Enrollment 19

Recruitment Details  
Pre-assignment Details  
Arm/Group Title DTCs (Well-differentiated Thyroid Carcinomas) MTC (Medullary Thyroid Cancer)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 16 3
Completed 16 3
Not Completed 0 0
Arm/Group Title DTCs (Well-differentiated Thyroid Carcinomas) MTC (Medullary Thyroid Cancer) Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 16 3 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 3 participants 19 participants
62
(40 to 77)
65
(54 to 67)
64
(40 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
Female
11
  68.8%
1
  33.3%
12
  63.2%
Male
5
  31.3%
2
  66.7%
7
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
 100.0%
3
 100.0%
19
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.3%
0
   0.0%
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  12.5%
0
   0.0%
2
  10.5%
White
13
  81.3%
3
 100.0%
16
  84.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
United States 15 3 18
Canada 1 0 1
ECOG (Eastern Cooperative Oncology Group) performance status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
0 (Fully active) 6 2 8
1(restricted in physically strenuous activity) 10 1 11
Site of metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
Lungs 16 0 16
Lymph nodes 8 1 9
Bones 4 2 6
Brain 4 0 4
1-2 sites 13 1 14
More than 2 sites 3 2 5
Previous therapies  
Measure Type: Number
Unit of measure:  Number of
Number Analyzed 16 participants 3 participants 19 participants
Surgery 15 3 18
Iodin-131 16 0 16
External beam radiation 6 2 8
Cytotoxic chemotherapy 6 2 8
Pathology of thyroid carcinoma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 3 participants 19 participants
Classic PTC 12 0 12
Follicular variant of PTC 2 0 2
FTC 1 0 1
Hurthle cell 1 0 1
MTC 0 3 3
1.Primary Outcome
Title Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per RECIST (Response Evaluation Criteria in Solid Tumors)
Arm/Group Title DTCs (Well-differentiated Thyroid Carcinomas) MTC (Medullary Thyroid Cancer)
Hide Arm/Group Description:
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.

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

Overall Number of Participants Analyzed 16 5
Measure Type: Number
Unit of Measure: percentage of participants
PR (Partial Response) 0 0
CR (Complete Response) 0 0
Stable disease 56 0
Time Frame NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.
Adverse Event Reporting Description 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
 
Arm/Group Title Arm I & Arm II
Hide Arm/Group Description

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

All-Cause Mortality
Arm I & Arm II
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I & Arm II
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I & Arm II
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  15/19 (78.95%)  15
Leukopenia  1  12/19 (63.16%)  12
Eye disorders   
Blurry vision  1  2/19 (10.53%)  2
Gastrointestinal disorders   
Abdominal Cramping  1  3/19 (15.79%)  3
Diarrhea  1  13/19 (68.42%)  13
Dry Mouth  1  5/19 (26.32%)  5
Flatulence/Bloating  1  6/19 (31.58%)  6
General pain  1  1/19 (5.26%)  1
Heartburn  1  3/19 (15.79%)  3
Mouth sores  1  4/19 (21.05%)  4
Nausea/Vomiting  1  13/19 (68.42%)  13
Taste changes  1  9/19 (47.37%)  9
General disorders   
Chest pain (muscle)  1  3/19 (15.79%)  3
Chills/Sweating  1  2/19 (10.53%)  2
Fatigue  1  15/19 (78.95%)  15
Injury, poisoning and procedural complications   
Thrombocytopenia  1  14/19 (73.68%)  14
Investigations   
Herpes zoster  1  2/19 (10.53%)  2
Weight loss  1  13/19 (68.42%)  13
Neutropenia  1  7/19 (36.84%)  7
Lymphopenia  1  2/19 (10.53%)  2
High PTT  1  2/19 (10.53%)  2
High P/INR  1  4/19 (21.05%)  4
Metabolism and nutrition disorders   
Anorexia  1  16/19 (84.21%)  16
Dehydration  1  2/19 (10.53%)  2
Hyperglycemia  1  10/19 (52.63%)  10
Musculoskeletal and connective tissue disorders   
General Weakness  1  7/19 (36.84%)  7
Muscle cramps  1  5/19 (26.32%)  5
Nervous system disorders   
Ataxia  1  3/19 (15.79%)  3
Dizziness  1  2/19 (10.53%)  2
Headache  1  2/19 (10.53%)  2
Memory loss  1  3/19 (15.79%)  3
Paresthesias  1  1/19 (5.26%)  1
Tremor  1  2/19 (10.53%)  2
Psychiatric disorders   
Anxiety  1  1/19 (5.26%)  1
Confusion  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchitis/pneumonia  1  3/19 (15.79%)  3
Cough  1  3/19 (15.79%)  3
Dsypnea  1  3/19 (15.79%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  8/19 (42.11%)  8
Nail changes  1  3/19 (15.79%)  3
Rash  1  2/19 (10.53%)  2
Vascular disorders   
Arterial thrombus  1  1/19 (5.26%)  1
Bruising/hematoma  1  3/19 (15.79%)  3
Deep vein thrombosis  1  1/19 (5.26%)  1
Flushing  1  2/19 (10.53%)  2
Hypertension  1  1/19 (5.26%)  1
Minor bleeding  1  5/19 (26.32%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Manisha Shah, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8629
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00134043     History of Changes
Other Study ID Numbers: NCI-2012-01468
04110
CDR0000439450
NCI-6902
OSU-04110
N01CM62207 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: April 18, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014