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Trial record 24 of 46 for:    disulfiram

Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)

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ClinicalTrials.gov Identifier: NCT01118741
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 6, 2014
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Disulfiram
Enrollment 19
Recruitment Details Recruitment dates: 06/04/2010 through 08/01/2011 in medical clinics
Pre-assignment Details Given the toxic effects of disulfiram when administered within 14 days of ingesting ethanol, participants were required to agree not to drink alcohol during the study and for 14 days after its completion.
Arm/Group Title Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Hide Arm/Group Description First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle. After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
Period Title: Overall Study
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose Total
Hide Arm/Group Description First 9 subjects were assigned to the low dose arm After 9 subjects were enrolled in the low dose arm, the high dose was opened. Total of all reporting groups
Overall Number of Baseline Participants 9 10 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  33.3%
8
  80.0%
11
  57.9%
>=65 years
6
  66.7%
2
  20.0%
8
  42.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 19 participants
66.6  (7.0) 62.6  (3.4) 64.5  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
10
 100.0%
19
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 10 participants 19 participants
9 10 19
1.Primary Outcome
Title Proportion of Subjects With a Demethylation Response at Each Dose Level
Hide Description For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Hide Arm/Group Description:
First 9 subjects were assigned to the low dose arm
[Not Specified]
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.22
(0.03 to 0.60)
.30
(0.07 to 0.65)
2.Secondary Outcome
Title Clinical Response
Hide Description

To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months.

Criteria used to assess: A rise in PSA noted at 6 months, greater than 50% over PSA value at baseline and > 2 ng/ml, above the nadir. The rise was confirmed by a second PSA value obtained at least 1 week from that reference value.

Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Hide Arm/Group Description:
First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: participants
5 0
Time Frame 7/16/10-9/27/11 (14 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Hide Arm/Group Description First 9 subjects were assigned to the low dose arm After 9 subjects were enrolled in the low dose arm, the high dose was opened.
All-Cause Mortality
Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Disulfiram Low Dose 250mg Dose Disulfiram High Dose 500mg Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/9 (66.67%)      8/10 (80.00%)    
Ear and labyrinth disorders     
HEARING LOSS  1  1/9 (11.11%)  1 0/10 (0.00%)  0
Eye disorders     
DIPLOPIA  1  1/9 (11.11%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
TASTE ALTERATION  1  2/9 (22.22%)  2 4/10 (40.00%)  4
DIARRHEA  1  1/9 (11.11%)  1 3/10 (30.00%)  3
CONSTIPATION  1  2/9 (22.22%)  2 2/10 (20.00%)  2
General disorders     
FATIGUE  1  6/9 (66.67%)  6 8/10 (80.00%)  8
Investigations     
ALT * 1  1/9 (11.11%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Carducci, MD
Organization: Johns Hopkins University
Phone: 410-614-3977
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01118741     History of Changes
Other Study ID Numbers: J0972
First Submitted: April 29, 2010
First Posted: May 7, 2010
Results First Submitted: December 13, 2013
Results First Posted: June 6, 2014
Last Update Posted: June 12, 2018