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Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00379197
First received: September 19, 2006
Last updated: April 13, 2017
Last verified: July 2013
Results First Received: April 22, 2015  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Naltrexone 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.

Participant Flow:   Overall Study
    Naltrexone
STARTED   13 
COMPLETED   8 
NOT COMPLETED   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Naltrexone

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.


Baseline Measures
   Naltrexone 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  50.0% 
>=65 years      4  50.0% 
Sex/Gender, Customized 
[Units: Participants]
 
Female only   8 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures
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1.  Primary:   Disease Response   [ Time Frame: Week 4 ]

2.  Secondary:   Median Time to Event   [ Time Frame: From Baseline to 1 Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: yeexx006@umn.edu



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 )
Study First Received: September 19, 2006
Results First Received: April 22, 2015
Last Updated: April 13, 2017