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Lithium for Low-Grade Neuroendocrine Tumors

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00501540
First received: July 13, 2007
Last updated: January 19, 2012
Last verified: January 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical and Biological Study of Lithium Carbonate in Patients With Low-Grade Neuroendocrine Tumors

Resource links provided by NLM:


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 [ Time Frame: Open to accrual 8/29/07, closed to accrual 6/24/09, data analysis completed 3/10/11 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lithium Carbonate
    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.
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
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501540

Locations
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Noelle LoConte, MD University of Wisconsin, Madison
Study Chair: Herbert Chen, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00501540     History of Changes
Other Study ID Numbers: CO07203, R21CA117117-01A2
Study First Received: July 13, 2007
Last Updated: January 19, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Lithium
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014