Trial Outcomes & Findings for An Initial Study of Lithium in Patients With Medullary Thyroid Cancer (NCT NCT00582712)

NCT ID: NCT00582712

Last Updated: 2019-12-09

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-12-09

Participant Flow

This study recruited participants from a large cancer research institution in Wisconsin from December 2007 through May 2008.

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	1
Overall Study Complicating disease requiring treatment	1

Baseline Characteristics

An Initial Study of Lithium in Patients With Medullary Thyroid Cancer

Baseline characteristics by cohort

Measure	Lithium Capsules n=5 Participants 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.
Age, Customized < 50 years of age	1 participants n=5 Participants
Age, Customized 50-59 years of age	2 participants n=5 Participants
Age, Customized 60-69 years of age	1 participants n=5 Participants
Age, Customized > 69 years of age	1 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: No data was ever analyzed, resulted, or published on this study.

Outcome measures

Outcome data not reported

Adverse Events

Lithium Capsules

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lithium Capsules n=5 participants at risk 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.
General disorders Death	60.0% 3/5 • Number of events 3 • Adverse event data were collected starting on of after Day 0 up to 4 years. Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks. AEs grades range from 1 (mild) to 5 (death).
General disorders Grade 3 fatigue	20.0% 1/5 • Number of events 1 • Adverse event data were collected starting on of after Day 0 up to 4 years. Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks. AEs grades range from 1 (mild) to 5 (death).
Nervous system disorders Grade 3 speech impairment	20.0% 1/5 • Number of events 1 • Adverse event data were collected starting on of after Day 0 up to 4 years. Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks. AEs grades range from 1 (mild) to 5 (death).
Nervous system disorders Grade 2 dizziness (vertigo)	20.0% 1/5 • Number of events 1 • Adverse event data were collected starting on of after Day 0 up to 4 years. Adverse events (AEs) were reported routinely at scheduled times during the trial. Additionally, some adverse events were reported in an expedited manner for more timely monitoring of patient safety and care. The serum lithium level was checked after 4-5 days of treatment by blood sample prior to daily dose 1 of lithium. If lithium level was outside the 0.8-1.2 mmol/L range, lithium levels were monitored weekly for 4 weeks and monthly after 4 weeks. AEs grades range from 1 (mild) to 5 (death).

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

University of Wisconsin Carbone Cancer Center

Phone: 608-265-0540

Email: clinicalresearch@surgery.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place