Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Lithium for Low-Grade Neuroendocrine Tumors
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, September 2008
Sponsors and Collaborators: University of Wisconsin, Madison
National Institutes of Health (NIH)
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00501540
  Purpose

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
Neuroendocrine Tumors
Drug: Lithium Carbonate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Lithium carbonate Lithium citrate
U.S. FDA Resources
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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • tumor response rate of patients with low-grade neuroendocrine tumors treated with lithium

Estimated Enrollment: 33
Study Start Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501540

Locations
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            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kyle D Holen, MD University of Wisconsin, Madison
Study Chair: Herbert Chen, MD University of Wisconsin, Madison
  More Information

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

Keywords provided by University of Wisconsin, Madison:
low-grade neuroendocrine tumors
lithium

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Lithium Carbonate
Neuroepithelioma
Lithium
Neuroendocrine Tumors

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009