An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582712
First received: December 19, 2007
Last updated: November 7, 2011
Last verified: November 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 13
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00582712

Contacts
Contact: Herbert Chen, MD 608-263-1387
Contact: Sarah Schaefer, NP 608-263-1387

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582712     History of Changes
Other Study ID Numbers: 2007-0195, CO 07312
Study First Received: December 19, 2007
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014