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Lithium for Low-Grade Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT00501540
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroendocrine Tumors
Intervention: Drug: Lithium Carbonate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled participants with low grade neuroendocrine tumors (NETs) from July 2007 through May 2009.

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

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.


Participant Flow:   Overall Study
    Lithium
STARTED   15 
COMPLETED   10 
NOT COMPLETED   5 
Death                5 



  Baseline Characteristics

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.
Participants with histologically confirmed metastatic low-grade neuroendocrine neoplasms were enrolled.

Reporting Groups
  Description
Lithium

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.


Baseline Measures
   Lithium 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  73.3% 
>=65 years      4  26.7% 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  73.3% 
>=65 years      4  26.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  60.0% 
Male      6  40.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      15 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      15 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Up to 4 years ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 4 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Dr. Noelle LoConte
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-265-5883
e-mail: ns3@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00501540     History of Changes
Other Study ID Numbers: CO07203
R21CA117117-01A2 ( U.S. NIH Grant/Contract )
2007-0065 ( Other Identifier: Institutional Review Board )
NCI-2011-00616 ( Registry Identifier: National Cancer Institute Clinical Trial Reporting Program )
First Submitted: July 13, 2007
First Posted: July 16, 2007
Results First Submitted: December 5, 2016
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017