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Sponsors and Collaborators: |
University of Wisconsin, Madison National Institutes of Health (NIH) |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00501540 |
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.
Condition | Intervention | Phase |
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Neuroendocrine Tumors |
Drug: Lithium Carbonate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors |
Estimated Enrollment: | 33 |
Study Start Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Cancer Connect 800-622-8922 | |
Contact: Kelly Richie 608-263-7283 | |
Principal Investigator: Kyle D Holen, MD |
Principal Investigator: | Kyle D Holen, MD | University of Wisconsin, Madison |
Study Chair: | Herbert Chen, MD | University of Wisconsin, Madison |
Study ID Numbers: | CO07203, NIH R21CA117117-01A2 |
Study First Received: | July 13, 2007 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00501540 |
Health Authority: | United States: Institutional Review Board |
low-grade neuroendocrine tumors lithium |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Lithium Carbonate |
Neuroepithelioma Lithium Neuroendocrine Tumors |
Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neoplasms, Nerve Tissue Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Neoplasms Therapeutic Uses Central Nervous System Agents Antidepressive Agents |