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

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumors

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Open to accrual 8/29/07, closed to accrual 6/24/09, data analysis completed 3/10/11

Safety Issue:


Principal Investigator

Noelle LoConte, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

June 2009

Related Keywords:

  • Neuroendocrine Tumors
  • low-grade neuroendocrine tumors
  • lithium
  • Neuroendocrine Tumors



University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164