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Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

This study has been terminated.
(Genitope suspend development of MyVax in light of the decision made by the Food and Drug Administration (FDA) March 6, 2008)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00006478
First received: November 6, 2000
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
Results First Received: October 19, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: autologous tumor cell vaccine
Biological: keyhole limpet hemocyanin
Biological: sargramostim
Procedure: adjuvant therapy

  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
No text entered.

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 vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF

Participant Flow:   Overall Study
    Vaccine Therapy  
STARTED     19  
COMPLETED     12  
NOT COMPLETED     7  
Vaccine could not be produced                 1  
Physician Decision                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Vaccine Therapy vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF

Baseline Measures
    Vaccine Therapy  
Number of Participants  
[units: participants]
 		  19  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  46.7  ± 10.68  
Gender  
[units: participants]
 		 
Female     10  
Male     9  
Region of Enrollment  
[units: participants]
 		 
United States     19  



  Outcome Measures

1.  Primary:   Number of Participants With Humoral and Cellular Immune Response   [ Time Frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression ]
  Show Outcome Measure 1

2.  Secondary:   Safety   [ Time Frame: At each immunization and at study completion ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Toxicity   [ Time Frame: At each immunization and at study completion ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Changes in Quantitative Bcl-2   [ Time Frame: 1 year post transplant evaluation and then annually until disease progression ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No serious adverse events were observed. No other (non-serious) adverse event were observed within the reporting threshold.

Reporting Groups
  Description
Vaccine Therapy vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF

Serious Adverse Events
    Vaccine Therapy  
Total, serious adverse events    
# participants affected / at risk     0/19 (0.00%)  




  Other Adverse Events
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  More Information
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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.


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
The Sponsor Genitope suspend development of MyVax in light of the decision made by the FDA March 6, 2008, therefore this trial was halted prematurely leaving insufficient data to analyze.  


Results Point of Contact:  
Name/Title: Bryan Ludwig, Regulatory Coordinator
Organization: University of Nebraska Medical Center Division of Oncology/Hematology
phone: 402-559-8071
e-mail: bmludwig@unmc.edu


No publications provided


Responsible Party: Julie M. Vose, UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00006478     History of Changes
Other Study ID Numbers: 260-00, P30CA036727, UNMC-260-00, GENITOPE-IND-8294
Study First Received: November 6, 2000
Results First Received: October 19, 2010
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration