Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer

This study has been terminated.
(Withdrawn due to toxicity)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00652899
First received: April 3, 2008
Last updated: November 6, 2012
Last verified: November 2012
Results First Received: August 20, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions: Biological: Allopurinol
Drug: Cyclophosphamide
Drug: Fludarabine phosphate
Radiation: total-body irradiation
Biological: Allogeneic natural killer cells
Biological: Aldesleukin

  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
Two patients did not receive all of study treatment per protocol.

Reporting Groups
  Description
All Patients Enrolled This group includes all patients consented to participate in this study.

Participant Flow:   Overall Study
    All Patients Enrolled  
STARTED     14  
COMPLETED     12  
NOT COMPLETED     2  
Death                 1  
Treating physician decision                 1  



  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
All Patients Enrolled This group includes all patients consented to participate in this study.

Baseline Measures
    All Patients Enrolled  
Number of Participants  
[units: participants]
  14  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 5.19  
Gender  
[units: participants]
 
Female     14  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product   [ Time Frame: Day 12-14 ]

2.  Secondary:   Number of Patients Per Disease Response   [ Time Frame: 1 Month After Natural Killer Cell Infusion (Day 30) ]

3.  Secondary:   Median Number of Days to Progression   [ Time Frame: From date of first treatment to disease progression ]

4.  Secondary:   Median Overall Survival Number of Days Patients Alive After Treatment   [ Time Frame: From first date on-study (treatment) to date of death ]


  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

Endpoint for association of clinical benefit response with donor/recipient KIR ligand matching status is not evaluable due to 0 complete responders.

Correlative laboratory objectives are irrelevant due to ineffectiveness of study regimen.



  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Melissa Geller, M.D.
Organization: University of Minnesota, Dept. Ob/Gyn
phone: 612-626-3111
e-mail: gelle005@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00652899     History of Changes
Other Study ID Numbers: 2007LS138, UMN-MT2007-19R, UMN-WCC-53, UMN-0712M23462
Study First Received: April 3, 2008
Results First Received: August 20, 2010
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration