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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00134043
First received: August 22, 2005
Last updated: July 23, 2014
Last verified: July 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

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


Participant Flow:   Overall Study
    DTCs (Well-differentiated Thyroid Carcinomas)     MTC (Medullary Thyroid Cancer)  
STARTED     16     3  
COMPLETED     16     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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

Total Total of all reporting groups

Baseline Measures
    DTCs (Well-differentiated Thyroid Carcinomas)     MTC (Medullary Thyroid Cancer)     Total  
Number of Participants  
[units: participants]
  16     3     19  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 40 to 77 )  
  65  
  ( 54 to 67 )  
  64  
  ( 40 to 77 )  
Gender  
[units: participants]
     
Female     11     1     12  
Male     5     2     7  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     16     3     19  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     0     2  
White     13     3     16  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     15     3     18  
Canada     1     0     1  
ECOG (Eastern Cooperative Oncology Group) performance status  
[units: participants]
     
0 (Fully active)     6     2     8  
1(restricted in physically strenuous activity)     10     1     11  
Site of metastasis  
[units: 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  
[units: numberĀ of]
     
Surgery     15     3     18  
Iodin-131     16     0     16  
External beam radiation     6     2     8  
Cytotoxic chemotherapy     6     2     8  
Pathology of thyroid carcinoma  
[units: 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  



  Outcome Measures

1.  Primary:   Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: manisha.shah@osumc.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

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
Study First Received: August 22, 2005
Results First Received: April 18, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration