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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Sponsor:
University of Wisconsin, Madison
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 13, 2007 | ||||||
First Posted Date ICMJE | July 16, 2007 | ||||||
Results First Submitted Date ICMJE | December 5, 2016 | ||||||
Results First Posted Date ICMJE | May 3, 2017 | ||||||
Last Update Posted Date | November 26, 2019 | ||||||
Study Start Date ICMJE | July 2007 | ||||||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 4 years ] Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.
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Original Primary Outcome Measures ICMJE |
tumor response rate of patients with low-grade neuroendocrine tumors treated with lithium | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Lithium for Low-Grade Neuroendocrine Tumors | ||||||
Official Title ICMJE | A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors | ||||||
Brief Summary | The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors. | ||||||
Detailed Description | Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neuroendocrine Tumors | ||||||
Intervention ICMJE | Drug: Lithium Carbonate
Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks.
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Study Arms ICMJE | Experimental: Lithium
Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment.
Intervention: Drug: Lithium Carbonate
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Publications * | Lubner SJ, Kunnimalaiyaan M, Holen KD, Ning L, Ndiaye M, Loconte NK, Mulkerin DL, Schelman WR, Chen H. A preclinical and clinical study of lithium in low-grade neuroendocrine tumors. Oncologist. 2011;16(4):452-7. doi: 10.1634/theoncologist.2010-0323. Epub 2011 Mar 10. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
15 | ||||||
Original Estimated Enrollment ICMJE |
33 | ||||||
Actual Study Completion Date ICMJE | June 2009 | ||||||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets. History of hypothyroid disease Significant, active cardiac disease
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00501540 | ||||||
Other Study ID Numbers ICMJE | 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 ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | University of Wisconsin, Madison | ||||||
Study Sponsor ICMJE | University of Wisconsin, Madison | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Wisconsin, Madison | ||||||
Verification Date | March 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |