An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

NCT00582712 | Terminated Phase 2 Results DMC

• 3 other identifiers: CO073122007-0195NCI-2011-00714
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)

  1 year

Study Arms (1)

Lithium Capsules

EXPERIMENTAL

Lithium carbonate

Drug: Lithium carbonate

Interventions

Lithium carbonate 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.

Lithium Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Uniersity of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: Director of Clinical Research
• Organization: University of Wisconsin Carbone Cancer Center

clinicalresearch@surgery.wisc.edu

608-265-0540

Study Officials

• Herbert Chen, MD

  University of Wisconsin Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: April 1, 2012
• Last Updated: December 9, 2019
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Locations

US (1)