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

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ClinicalTrials.gov 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 : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Constantinou, Brown University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Melanoma
Prostate Cancer
Renal Cancer
Intervention Drug: Naltrexone
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Naltrexone
Hide Arm/Group Description

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

Naltrexone

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Low Dose Naltrexone
Hide Arm/Group Description

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

Naltrexone

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
79.4
(68 to 89)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
7
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
1
  14.3%
Male
6
  85.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
Hide Description Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).
Time Frame approximately every 3 months CT, every month physical, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melanoma: Low Dose Naltrexone Prostate Cancer- Low Dose Naltrexone
Hide Arm/Group Description:

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

Naltrexone

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

Naltrexone

Overall Number of Participants Analyzed 1 6
Measure Type: Number
Unit of Measure: participants
stable disease by RECIST 0 2
progression of disease by PSA 0 6
progression via RECIST 0 1
progression clinical 1 0
2.Secondary Outcome
Title To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.
Hide Description Defined by number of patients who experienced a SAE
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Naltrexone
Hide Arm/Group Description:

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

Naltrexone

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Monthly and 30 days post last dose of drug (approximately 9 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Naltrexone
Hide Arm/Group Description

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

Naltrexone

All-Cause Mortality
Low Dose Naltrexone
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Low Dose Naltrexone
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Naltrexone
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Investigations   
Anemia   4/7 (57.14%)  4
RBC   1/7 (14.29%)  1
infection   1/7 (14.29%)  1
abd pain   1/7 (14.29%)  1
kidney pain   1/7 (14.29%)  1
fatigue   3/7 (42.86%)  3
anorexia   2/7 (28.57%)  2
nausea   1/7 (14.29%)  1
upset stomach   1/7 (14.29%)  1
diarrhea   1/7 (14.29%)  1
leg cyst   1/7 (14.29%)  1
LFT   1/7 (14.29%)  1
seg neutrophils   1/7 (14.29%)  1
constipation   1/7 (14.29%)  1
dyspnea   1/7 (14.29%)  1
achilles pain   1/7 (14.29%)  1
pain scalp   1/7 (14.29%)  1
scalp lesion- Moh's   1/7 (14.29%)  1
weight loss   1/7 (14.29%)  1
PLT   1/7 (14.29%)  1
Rash- thigh   1/7 (14.29%)  1
creatinine   1/7 (14.29%)  1
edema   1/7 (14.29%)  1
Pain- shoulder   1/7 (14.29%)  1
pain-hip   1/7 (14.29%)  1
insomnia   1/7 (14.29%)  1
Indicates events were collected by systematic assessment
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: Maria Constantinou, MD
Organization: Brown University Oncology Research Group
Phone: 401-863-3000
EMail: Kayla_rosati@brown.edu
Layout table for additonal information
Responsible Party: Maria Constantinou, Brown University
ClinicalTrials.gov Identifier: NCT01650350    
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: February 15, 2019