Medullary Thyroid CancerPhase 2NCT00582712
An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
A Phase 2 study testing Lithium carbonate in people with Medullary Thyroid Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- Lithium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 21Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniersity of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate
- Conditions
- Medullary Thyroid Cancer
- Being tested
- Lithium carbonate
- Keywords
- medullary thyroid cancer, lithium
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium carbonateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lithium Capsules | Experimental | Lithium carbonate Receives: Drug: Lithium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionApr 2012
Why it stopped: Budget/Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Chen, MD, Principal investigator, University of Wisconsin Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582712
- Sponsor's protocol ID
- CO07312
- Other IDs
- 2007-0195, NCI-2011-00714
- Status last verified
- Oct 2016
- First submitted
- 19 Dec 2007
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Study of Lithium in Patients With Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00582712
- Acronym / sponsor ID
- CO07312
- Conditions
- Medullary Thyroid Cancer
- Keywords
- medullary thyroid cancer, lithium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Budget/Funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective is to evaluate the tumor response rate of patients with MTC treated with Lithium carbonate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium Capsules | Experimental | Drug: Lithium carbonateLithium carbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- The following laboratory values obtained within 14 days prior to registration:
- ECOG performance status of 2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium carbonateLithium 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. | Drug | Lithium Capsules |
Primary outcome
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Related trials for Medullary Thyroid Cancer
RecruitingObservational study
Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer
Non-Medullary Thyroid Cancer
Active, not recruitingObservational study
Natural History Study of Children and Adults With Medullary Thyroid Cancer
Medullary Thyroid Cancer
RecruitingObservational study
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC )
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
SMARCB1-Deficient Malignancies, Epithelioid Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Chen, MD principal investigator
University of Wisconsin Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lithium carbonate in people with Medullary Thyroid Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.