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 : November 26, 2019
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Neuroendocrine Tumors |
Intervention |
Drug: Lithium Carbonate |
Enrollment | 15 |
Recruitment Details | This study enrolled participants with low grade neuroendocrine tumors (NETs) from July 2007 through May 2009. |
Pre-assignment Details |
Arm/Group Title | Lithium |
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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. |
Period Title: Overall Study | |
Started | 15 |
Completed | 10 |
Not Completed | 5 |
Reason Not Completed | |
Death | 5 |
Arm/Group Title | Lithium | |
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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. |
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Overall Number of Baseline Participants | 15 | |
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Participants with histologically confirmed metastatic low-grade neuroendocrine neoplasms were enrolled.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
11 73.3%
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>=65 years |
4 26.7%
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
11 73.3%
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>=65 years |
4 26.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | |
Female |
9 60.0%
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Male |
6 40.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
15 100.0%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
15 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 15 participants |
15 |
Name/Title: | Dr. Noelle LoConte |
Organization: | University of Wisconsin Carbone Cancer Center |
Phone: | 608-265-5883 |
EMail: | ns3@medicine.wisc.edu |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00501540 |
Other Study ID Numbers: |
CO07203 R21CA117117-01A2 ( U.S. NIH Grant/Contract ) H-2007-0065 ( Other Identifier: Institutional Review Board ) NCI-2011-00616 ( Registry Identifier: NCI Trial ID ) A534260 ( Other Identifier: UW Madison ) SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison ) |
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: | November 26, 2019 |