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

This study has been terminated.
(Study stopped 10/24/13 secondary to lack of patients/slow enrollment)
Information provided by (Responsible Party):
Maria Constantinou, Brown University
ClinicalTrials.gov Identifier:
First received: July 24, 2012
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Melanoma
Prostate Cancer
Renal Cancer
Intervention: Drug: Naltrexone

  Participant Flow
  Hide 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  
STARTED     7  

  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
Low Dose Naltrexone

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


Baseline Measures
    Low Dose Naltrexone  
Number of Participants  
[units: participants]
[units: years]
Mean (Full Range)
  79.4   (68 to 89)  
[units: participants]
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     7  
[units: participants]
Female     1  
Male     6  
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.   Safety Issue:   Yes

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
  Hide 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
No text entered.

  More Information
  Hide 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
e-mail: Kayla_rosati@brown.edu

Responsible Party: Maria Constantinou, Brown University
ClinicalTrials.gov Identifier: NCT01650350     History of Changes
Other Study ID Numbers: BrUOG 275
Study First Received: July 24, 2012
Results First Received: August 14, 2014
Last Updated: July 27, 2015
Health Authority: United States: Food and Drug Administration