Lithium for Low-Grade Neuroendocrine Tumors
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: Lithium Carbonate
Intervention description: 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.
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low-grade neuroendocrine tumors; lithium

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.
    

Eligibility criteria:

        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 the University of Wisconsin Carbone Cancer Center
             (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
             (cyclooxygenase-2) 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.