Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lithium for Low-Grade Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501540
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroendocrine Tumors
Intervention Drug: Lithium Carbonate
Enrollment 15
Recruitment Details This study enrolled participants with low grade neuroendocrine tumors (NETs) from July 2007 through May 2009.
Pre-assignment Details  
Arm/Group Title Lithium
Hide Arm/Group Description

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Death             5
Arm/Group Title Lithium
Hide Arm/Group Description

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Participants with histologically confirmed metastatic low-grade neuroendocrine neoplasms were enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), small changes that do not meet the above criteria.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium
Hide Arm/Group Description:

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Partial Response (PR) 0
Progressive Disease (PD) 0
Stable Disease (SD) 8
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival is measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression. If a participant did not experience an event of disease progression or death at the time of analysis (03/10/2011), then the patient's data was censored at the date of the last available evaluation.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium
Hide Arm/Group Description:

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
4.50
(2.99 to 4.50)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival for a participant is defined as the number of days from the day of first Lithium administration to the participant's death. As of the time of analysis (03/10/2011), median overall survival duration was not reached.
Time Frame Up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
The median OS time had not been reached.
Arm/Group Title Lithium
Hide Arm/Group Description:

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: participants
NA [1] 
(NA to NA)
[1]
50% of participants had not died at the time that the final statistics were run.
Time Frame Adverse event data were collected on or after Day 0 through 4 years.
Adverse Event Reporting Description Adverse events were reported in a routine manner at scheduled times during the trial. Additionally, certain adverse events were reported in an expedited manner for more timely monitoring of patient safety and care.
 
Arm/Group Title Lithium
Hide Arm/Group Description

Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.

Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks.

All-Cause Mortality
Lithium
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lithium
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Gastrointestinal disorders   
Ileus, GI  1  1/15 (6.67%)  1
Stricture/stenosis  1  1/15 (6.67%)  1
General disorders   
Pain  1  2/15 (13.33%)  3
Investigations   
Creatinine  1  1/15 (6.67%)  1
Hemoglobin  1  1/15 (6.67%)  1
Sodium  1  1/15 (6.67%)  1
Metabolism and nutrition disorders   
Glucose  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lithium
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Blood and lymphatic system disorders   
Anemia  1  3/15 (20.00%)  5
Elevated white blood count  1  1/15 (6.67%)  1
Stricture of mesenteric artery  1  1/15 (6.67%)  1
Thrombocytopenia  1  4/15 (26.67%)  9
Endocrine disorders   
Elevated TSH  1  1/15 (6.67%)  2
High Parathyroid Hormone  1  1/15 (6.67%)  2
Hyperthyroidism  1  1/15 (6.67%)  3
Gastrointestinal disorders   
Abdominal pain  1  9/15 (60.00%)  14
Anorexia  1  6/15 (40.00%)  7
Constipation  1  2/15 (13.33%)  3
Diarrhea  1  7/15 (46.67%)  15
Gas pain  1  1/15 (6.67%)  1
Hemorrhoids  1  1/15 (6.67%)  1
Increased gas  1  1/15 (6.67%)  1
Nausea  1  7/15 (46.67%)  9
Vomiting  1  4/15 (26.67%)  6
General disorders   
Cold  1  1/15 (6.67%)  1
Cold sensation in hands  1  1/15 (6.67%)  1
Edema  1  1/15 (6.67%)  1
Emotional changes  1  1/15 (6.67%)  1
Fatigue  1  11/15 (73.33%)  20
Fever  1  1/15 (6.67%)  1
Panic Attacks  1  1/15 (6.67%)  1
Hepatobiliary disorders   
Acute cholecystitis  1  1/15 (6.67%)  1
Investigations   
Creatinine  1  4/15 (26.67%)  6
High ALT  1  1/15 (6.67%)  1
High AST  1  1/15 (6.67%)  1
High INR  1  1/15 (6.67%)  1
Hyperbilirubinemia  1  1/15 (6.67%)  8
Hypercalcemia  1  2/15 (13.33%)  3
Lymphopenia  1  4/15 (26.67%)  9
Metabolism and nutrition disorders   
Dehydration  1  1/15 (6.67%)  1
Hyperglycemia  1  5/15 (33.33%)  15
Hypocalcemia  1  1/15 (6.67%)  1
Hypokalemia  1  1/15 (6.67%)  5
Hyponatremia  1  1/15 (6.67%)  1
Hypophosphatemia  1  1/15 (6.67%)  1
Low Anion Gap  1  1/15 (6.67%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  1/15 (6.67%)  1
Shaky legs  1  1/15 (6.67%)  1
Unsteady Gait  1  1/15 (6.67%)  1
Nervous system disorders   
Dizziness  1  2/15 (13.33%)  2
Headache  1  1/15 (6.67%)  1
Memory Impairment  1  2/15 (13.33%)  2
Tremors  1  5/15 (33.33%)  6
Psychiatric disorders   
Cognitive disturbance/confusion  1  2/15 (13.33%)  2
Insomnia  1  2/15 (13.33%)  4
Renal and urinary disorders   
Frequency  1  1/15 (6.67%)  1
Low EGFR  1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/15 (6.67%)  1
Dyspnea  1  1/15 (6.67%)  1
Nasal congestion  1  1/15 (6.67%)  1
Sore throat  1  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Puritis  1  1/15 (6.67%)  1
Vascular disorders   
Flushing  1  1/15 (6.67%)  1
Hot flashes  1  1/15 (6.67%)  1
Ischemia of small bowel leading to necrosis  1  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Noelle LoConte
Organization: University of Wisconsin Carbone Cancer Center
Phone: 608-265-5883
EMail: ns3@medicine.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00501540     History of Changes
Other Study ID Numbers: CO07203
R21CA117117-01A2 ( U.S. NIH Grant/Contract )
2007-0065 ( Other Identifier: Institutional Review Board )
NCI-2011-00616 ( Registry Identifier: National Cancer Institute Clinical Trial Reporting Program )
First Submitted: July 13, 2007
First Posted: July 16, 2007
Results First Submitted: December 5, 2016
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017