Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098813
First received: December 8, 2004
Last updated: May 13, 2014
Last verified: October 2013
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer
Interventions: Drug: romidepsin
Other: laboratory biomarker analysis
Procedure: positron emission tomography

  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
Protocol Open to Accrual 10/12/2004 Protocol Closed to Accrual 04/22/2008 Primary Completion Date 08/11/2009 Recruitment Location is the medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

Participant Flow:   Overall Study
    Treatment (Romidepsin)  
STARTED     20  
COMPLETED     1  
NOT COMPLETED     19  
Death                 8  
Protocol Violation                 1  
Withdrawal by Subject                 7  
Progression of Disease                 1  
Other complicating disease                 1  
Reversal of RAI resistance                 1  



  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
Treatment (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

Baseline Measures
    Treatment (Romidepsin)  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     8  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 34.64823228  
Gender  
[units: participants]
 
Female     10  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria   [ Time Frame: From start of treatment to 8 weeks ]


  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: Dr. David Pfister
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646-888-4237
e-mail: pfisterd@mskcc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098813     History of Changes
Other Study ID Numbers: NCI-2012-01458, 04-059, N01CM62206, CDR0000396783
Study First Received: December 8, 2004
Results First Received: October 29, 2013
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration