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An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

This study has been terminated.
(Budget/Funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582712
First Posted: December 28, 2007
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate

Condition Intervention Phase
Medullary Thyroid Cancer Drug: Lithium carbonate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 1 year ]

Enrollment: 5
Study Start Date: January 2008
Study Completion Date: April 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lithium Capsules
Lithium carbonate
Drug: Lithium carbonate
Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.2; Continue until progressive disease/unacceptable toxicity; Evaluate every 4 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC.
  • Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease.
  • Disease progression is not required for this trial

    • 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could include total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient).
    • 3 weeks from the completion of radiation therapy to study registration
  • The following laboratory values obtained within 14 days prior to registration:

    • Absolute neutrophils count (ANC) ≥ 1000/mm3
    • Platelets ≥ 75,000/mm3
    • Hemoglobin ≥ 8.0 g/dL
    • Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN)
    • AST greater than or equal to 3 X ULN or greater than or equal to 5 X ULN if liver metastases are present
    • Creatinine greater than or equal to ULN
    • Serum sodium within normal limits
  • ECOG performance status of 2
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
  • Availability of tissue specimens to be analyzed for pathologic confirmation.
  • Age ≥ 18 years.
  • Women must not be pregnant or lactating due to the deleterious effects of Lithium carbonate on a fetus or small child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
  • 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 its derivatives.
  • Patients are not allowed to be on concurrent chemotherapy or radiation therapy.

Exclusion Criteria:

  • 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).
  • Significant, active cardiac disease
  • Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors.
  • Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory.
  • Patients already taking Lithium for any reason are not allowed on study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582712


Locations
United States, Wisconsin
Uniersity of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Herbert Chen, MD University of Wisconsin Cancer Center
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582712     History of Changes
Other Study ID Numbers: CO07312
2007-0195 ( Other Identifier: Institutional Review Board )
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: October 18, 2016
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016

Keywords provided by University of Wisconsin, Madison:
medullary thyroid cancer
lithium

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs