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An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

This study has been terminated.
(Budget/Funding)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582712
First received: December 19, 2007
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: October 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Medullary Thyroid Cancer
Intervention: Drug: Lithium carbonate

  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
This study recruited participants from a large cancer research institution in Wisconsin from December 2007 through May 2008.

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
Lithium Capsules Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.

Participant Flow:   Overall Study
    Lithium Capsules
STARTED   5 
COMPLETED   1 
NOT COMPLETED   4 
Adverse Event                1 
Lack of Efficacy                1 
Withdrawal by Subject                1 
Complicating disease requiring treatment                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.
This study enrolled participants with Medullary Thyroid Cancer (MTC).

Reporting Groups
  Description
Lithium Capsules Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.

Baseline Measures
   Lithium Capsules 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age, Customized 
[Units: Participants]
 
< 50 years of age   1 
50-59 years of age   2 
60-69 years of age   1 
> 69 years of age   1 
Gender 
[Units: Participants]
 
Female   1 
Male   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   5 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   5 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures

1.  Primary:   Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: 1 year ]


  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 NOT 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: Director of Clinical Research
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-265-0540
e-mail: clinicalresearch@surgery.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582712     History of Changes
Other Study ID Numbers: CO07312
2007-0195 ( Other Identifier: Institutional Review Board )
Study First Received: December 19, 2007
Results First Received: October 18, 2016
Last Updated: October 18, 2016