Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer

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. Identifier: NCT01650350
Recruitment Status : Terminated (Study stopped 10/24/13 secondary to lack of patients/slow enrollment)
First Posted : July 26, 2012
Results First Posted : July 27, 2015
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Maria Constantinou, Brown University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Melanoma
Prostate Cancer
Renal Cancer
Intervention: Drug: Naltrexone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Low Dose Naltrexone

LDN, 5 mg/day-(1 cycle = 28 days).


Participant Flow:   Overall Study
    Low Dose Naltrexone

  Baseline Characteristics

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
Low Dose Naltrexone

LDN, 5 mg/day-(1 cycle = 28 days).


Baseline Measures
   Low Dose Naltrexone 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (68 to 89) 
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      7 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      1  14.3% 
Male      6  85.7% 
Region of Enrollment 
[Units: Participants]
United States   7 

  Outcome Measures

1.  Primary:   Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST   [ Time Frame: approximately every 3 months CT, every month physical, up to 6 months ]

2.  Secondary:   To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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:  
Name/Title: Maria Constantinou, MD
Organization: Brown University Oncology Research Group
phone: 401-863-3000

Responsible Party: Maria Constantinou, Brown University Identifier: NCT01650350     History of Changes
Other Study ID Numbers: BrUOG 275
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: August 14, 2014
Results First Posted: July 27, 2015
Last Update Posted: November 17, 2017