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Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00379197
Recruitment Status : Terminated (slow accrual)
First Posted : September 21, 2006
Results First Posted : May 19, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: naltrexone
Procedure: PET scan
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone
Hide Arm/Group Description Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
Period Title: Overall Study
Started 13
Completed 8
Not Completed 5
Arm/Group Title Naltrexone
Hide Arm/Group Description

Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).

naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.

Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  50.0%
>=65 years
4
  50.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female only Number Analyzed 8 participants
8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Disease Response
Hide Description A response is the number of participants whose tumor demonstrated a decrease in FDG uptake (SUV) by 50% or greater in at least one of the metastatic sites as measured by PET imaging at the end of 4 weeks of treatment compared to baseline.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Treatment
Hide Arm/Group Description:
Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Median Time to Event
Hide Description First time when maximum SUV is higher than that at baseline within 1 year of study entry.
Time Frame From Baseline to 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One of the 8 participants did not have an increase in SUV above baseline at 8 weeks, but no further PET scans were performed after 8 weeks. The reported median value is for the remaining 7 participants.
Arm/Group Title Naltrexone
Hide Arm/Group Description:

Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.

naltrexone: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.

PET scan: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: weeks
8
(4 to 8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Treatment
Hide Arm/Group Description Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
All-Cause Mortality
Naltrexone Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Treatment
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone Treatment
Affected / at Risk (%)
Total   4/8 (50.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/8 (12.50%) 
Pain right axillary node  1  1/8 (12.50%) 
Pancytopenia  1  1/8 (12.50%) 
Cardiac disorders   
Palpitations  1  1/8 (12.50%) 
Gastrointestinal disorders   
Abdominal bloating  1  1/8 (12.50%) 
right upper quadrant abdominal pain  1  1/8 (12.50%) 
increased thirst  1  1/8 (12.50%) 
Ascites  1  1/8 (12.50%) 
Nausea  1  1/8 (12.50%) 
Hepatobiliary disorders   
Cirrhotic Appearing Liver  1  1/8 (12.50%) 
Investigations   
Weight Gain  1  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders   
pain - muscular  1  1/8 (12.50%) 
Psychiatric disorders   
Insomnia  1  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Shortness of breath  1  1/8 (12.50%) 
cough  1  1/8 (12.50%) 
Skin and subcutaneous tissue disorders   
Itching  1  1/8 (12.50%) 
mild erythema  1  1/8 (12.50%) 
hand and foot syndrome  1  1/8 (12.50%) 
Vascular disorders   
Hot Flashes  1  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Douglas Yee, MD
Organization: University of Minnesota, Dept. Medicine
Phone: 612-273-5700
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00379197     History of Changes
Other Study ID Numbers: 2006LS016
UMN-0604M85308 ( Other Identifier: IRB, University of Minnesota )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: April 22, 2015
Results First Posted: May 19, 2017
Last Update Posted: December 28, 2017