LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma (DEBDOX)

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: NCT01010984
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
University of Louisville
Thomas Jefferson University
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stage IV Melanoma
Intervention: Device: LC beads loaded with Doxorubicin

  Participant Flow

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
Tace Using LC Beads Loaded With 150mg of Doxorubicin Tace using LC beads loaded with 150mg of Doxorubicin. May have up to 6 treatments.

Participant Flow:   Overall Study
    Tace Using LC Beads Loaded With 150mg of Doxorubicin

  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
Transcatheter Arterial Chemoembolization

TACE using LC beads loaded with Doxorubicin

LC beads loaded with Doxorubicin: During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg

Baseline Measures
   Transcatheter Arterial Chemoembolization 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      14  70.0% 
>=65 years      6  30.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      7  35.0% 
Male      13  65.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      20 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  Outcome Measures

1.  Primary:   Incidence of Adverse Events   [ Time Frame: Date of surgery through 2 years post procedure or until patient death ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Percentage of tumor response assessed up to 1 year post treatment. ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Robert Martin, MD, PhD
Organization: University of Louisville
phone: 502-629-3355

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Robert C. Martin, University of Louisville Identifier: NCT01010984     History of Changes
Other Study ID Numbers: G090097
First Submitted: November 4, 2009
First Posted: November 10, 2009
Results First Submitted: April 30, 2017
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018