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

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: NCT00652899
Recruitment Status : Terminated (Withdrawn due to toxicity)
First Posted : April 4, 2008
Results First Posted : September 15, 2010
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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

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

Participant Flow:   Overall Study
    All Patients Enrolled
Death                1 
Treating physician decision                1 

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

Baseline Measures
   All Patients Enrolled 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      14 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 55  (5.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      14 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   14 

  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

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

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

Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00652899     History of Changes
Other Study ID Numbers: 2007LS138
UMN-MT2007-19R ( Other Identifier: Blood and Marrow Transplantation Program )
UMN-WCC-53 ( Other Identifier: Women's Cancer Center, U of M )
UMN-0712M23462 ( Other Identifier: IRB, University of Minnesota )
First Submitted: April 3, 2008
First Posted: April 4, 2008
Results First Submitted: August 20, 2010
Results First Posted: September 15, 2010
Last Update Posted: December 28, 2017