An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

• ClinicalTrials.gov Identifier: NCT00582712
• Recruitment Status: Terminated
• First Posted: December 28, 2007
• Results First Posted: December 12, 2016
• Last Update Posted: December 9, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate

Condition or disease	Intervention/treatment	Phase
Medullary Thyroid Cancer	Drug: Lithium carbonate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• 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
• Study Start Date: January 2008
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

Additional Information:

University of Wisconsin Carbone Cancer Center 

• 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 ); NCI-2011-00714 ( Registry Identifier: NCI Trial ID )
• First Posted: December 28, 2007
• Results First Posted: December 12, 2016
• Last Update Posted: December 9, 2019
• Last Verified: October 2016

Keywords provided by University of Wisconsin, Madison:

medullary thyroid cancer; lithium

Additional relevant MeSH terms:

Carcinoma, Neuroendocrine; Carcinoma; Thyroid Neoplasms; Thyroid Diseases; 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; 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