An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

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

Study Overview

• Status: Terminated
• Conditions: Medullary Thyroid Cancer
• Intervention / Treatment: Drug: Lithium carbonate

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Uniersity of Wisconsin Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)	1 year

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Herbert Chen, MD, University of Wisconsin Cancer Center

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: lithium; medullary thyroid cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CO07312; 2007-0195 (Other Identifier: Institutional Review Board); NCI-2011-00714 (Registry Identifier: NCI Trial ID)