Medullary Thyroid Cancer
Conditions
Keywords
medullary thyroid cancer, lithium
Brief summary
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate
Interventions
DRUGLithium 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) | 1 year |
Countries
United States
Participant flow
Recruitment details
This study recruited participants from a large cancer research institution in Wisconsin from December 2007 through May 2008.
Participants by arm
| Arm | Count |
|---|---|
| Lithium Capsules Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Complicating disease requiring treatment | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lithium Capsules |
|---|---|
| Age, Customized 50-59 years of age | 2 participants |
| Age, Customized < 50 years of age | 1 participants |
| Age, Customized 60-69 years of age | 1 participants |
| Age, Customized > 69 years of age | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 4 / 5 |
Outcome results
Primary
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 1 year
Population: No data was ever analyzed, resulted, or published on this study.