An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

NCT ID: NCT00582712

Last Updated: 2019-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-04-30

Brief Summary

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

Conditions

Medullary Thyroid Cancer

Keywords

medullary thyroid cancer; lithium

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lithium Capsules

Lithium carbonate

Group Type: EXPERIMENTAL

Lithium carbonate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert Chen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Cancer Center

Locations

Uniersity of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

2007-0195

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00714

Identifier Type: REGISTRY

Identifier Source: secondary_id

CO07312

Identifier Type: -

Identifier Source: org_study_id