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Lithium for Low-Grade Neuroendocrine Tumors

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroendocrine Tumors

Intervention: Lithium Carbonate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Noelle LoConte, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
Herbert Chen, MD, Study Chair, Affiliation: University of Wisconsin, Madison


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.

Clinical Details

Official title: A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: tumor response rate of patients with low-grade neuroendocrine tumors treated with lithium

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms.

Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.

- Must have measurable disease

- Must have radiographic evidence of disease progression following any prior systemic

therapy, chemoembolization, bland embolization, surgery, or observation.

- Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other

systemic therapy or local liver therapy to study registration

- Must be ≥ 3 weeks from the completion of radiation therapy to study registration

- The following laboratory values are to be obtained within 14 days prior to

registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8. 0 g/dL; Total bilirubin less than or equal 2. 0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits

- PS = 0-2

- Capable of understanding the investigational nature, potential risks and benefits fo

the study and able to provide valid informed consent.

- Must have available tissue specimens to be analyzed for pathologic confirmation.

- Age ≥ 18 years.

- Women must not be pregnant or lactating.

- Women of childbearing potential and sexually active males are required to use an

accepted and effective method of contraception.

- Patients must not have known history of allergic reactions or adverse reactions to

Lithium or derivatives.

- Patients are not allowed to be on concurrent chemotherapy or radiation therapy.

- Patients are excluded if they have any of the following:

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

- Patients must not be taking the following medications: diuretics, ACE inhibitors,

NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, COX2 inhibitors, citalopram, clovoxamine, escitalopram, femoxetine, fluoxetine, fluvoxamine, paroxatine, sertraline, and zimeldine.

- Must be willing to undergo a tumor biopsy pre and post therapy.

- Patients with a concurrent malignancy are allowed on study as long as the patient is

not undergoing active treatment for their disease.

- Patients already taking Lithium for any reason are not allowed on study.

Locations and Contacts

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin 53792, United States
Additional Information

Starting date: July 2007
Last updated: January 19, 2012

Page last updated: August 23, 2015

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