Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma

This study has been completed.
Sponsor:
Collaborators:
American Society of Clinical Oncology
Society of Surgical Oncology (SSO)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00101166
First received: January 7, 2005
Last updated: November 16, 2012
Last verified: September 2012
Results First Received: October 18, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Intervention: Biological: Bystander-Based Autologous Tumor Cell Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
43 patients with Stage IV melanoma were enrolled between November 2004 and May 2007. Fifteen of these patients did not receive any vaccine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vaccine Therapy

Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.

Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.


Participant Flow:   Overall Study
    Vaccine Therapy  
STARTED     28  
COMPLETED     18  
NOT COMPLETED     10  
progressive disease                 10  



  Baseline Characteristics
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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
Vaccine Therapy

Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.

Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.


Baseline Measures
    Vaccine Therapy  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 24 to 87 )  
Gender  
[units: participants]
 
Female     8  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
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1.  Primary:   Number of Participants With Partial Response   [ Time Frame: Average of 14 months ]

2.  Secondary:   Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment   [ Time Frame: Average of 14 months ]

3.  Secondary:   Number of Participants With Stable Disease   [ Time Frame: Average of 14 months ]

4.  Secondary:   Time to Progression (TTP) in Months   [ Time Frame: Average of 14 months ]

5.  Secondary:   Overall Survival (OS) in Months   [ Time Frame: Average of 14 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Due to the heterogeneity of the patient population, results were mainly descriptive in nature.  


Results Point of Contact:  
Name/Title: Dr. Sophie Dessureault
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-1965
e-mail: sophie.dessureault@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00101166     History of Changes
Other Study ID Numbers: MCC-13639, 0407-657
Study First Received: January 7, 2005
Results First Received: October 18, 2012
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration