We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dendritic Cells (DC) Vaccine for Metastatic Melanoma

This study has been terminated.
(Closed to accrual in March 2009 for slow accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042366
First Posted: January 5, 2010
Last Update Posted: August 16, 2017
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.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Kirkwood, University of Pittsburgh
Results First Submitted: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Melanoma
Intervention: Biological: Vaccination

  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
Although 16 subjects were enrolled, one subject was referred to hospice and never began the study.

Reporting Groups
  Description
DCs Co-cultured With Melanoma Cells

DCs co-cultured with melanoma cells

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

DCs Pulsed With Tumor Cell Lysates

DCs pulsed with tumor cell lysates

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

DCs Fused With Tumor Cells

DCs fused with tumor cells

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.


Participant Flow:   Overall Study
    DCs Co-cultured With Melanoma Cells   DCs Pulsed With Tumor Cell Lysates   DCs Fused With Tumor Cells
STARTED   5   6   4 
COMPLETED   5   6   4 
NOT COMPLETED   0   0   0 



  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
  Description
DCs Co-cultured With Melanoma Cells

DCs co-cultured with melanoma cells

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

DCs Pulsed With Tumor Cell Lysates

DCs pulsed with tumor cell lysates

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

DCs Fused With Tumor Cells

DCs fused with tumor cells

Vaccination: Subjects will receive as an outpatient 4 weekly ultrasound-guided intra/peri-lymph nodal administrations of the autologous tumor dendritic cell vaccine. The dose of the autologous tumor cell dendritic cells/vaccine will be 1-5 X 106.

Leukapheresis: All selected subjects will undergo leukapheresis. Two and a half times the subject's blood volume will be processed per procedure. A single 4 hour leukapheresis will be done.

Total Total of all reporting groups

Baseline Measures
   DCs Co-cultured With Melanoma Cells   DCs Pulsed With Tumor Cell Lysates   DCs Fused With Tumor Cells   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   6   4   15 
Age 
[Units: Years]
Median (Full Range)
 66 
 (43 to 72) 
 44.5 
 (32 to 59) 
 54 
 (49 to 81) 
 49 
 (32 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  80.0%      3  50.0%      2  50.0%      9  60.0% 
Male      1  20.0%      3  50.0%      2  50.0%      6  40.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Delayed Type Hypersensitivity (DTH) Response   [ Time Frame: 12 mo ]

2.  Primary:   ELISpot Response to Melanoma   [ Time Frame: 12 mo ]


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


Results Point of Contact:  
Name/Title: John Kirkwood, MD
Organization: University of Pittsburgh
phone: (412) 623-7707
e-mail: KirkwoodJM@upmc.edu



Responsible Party: John Kirkwood, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01042366     History of Changes
Other Study ID Numbers: UPCI 01-171
5P01CA073743 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2010
First Posted: January 5, 2010
Results First Submitted: January 13, 2016
Results First Posted: August 16, 2017
Last Update Posted: August 16, 2017



To Top