Clinical trial NCT00582712: An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
Official title: An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Medullary Thyroid Cancer
Keywords: medullary thyroid cancer
lithium
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Uniersity of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Cancer Center
name: Herbert Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: