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

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ClinicalTrials.gov 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Recruitment Status : Terminated (Withdrawn due to toxicity)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
Sponsor:
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
Enrollment 14
Recruitment Details  
Pre-assignment Details Two patients did not receive all of study treatment per protocol.
Arm/Group Title All Patients Enrolled
Hide Arm/Group Description This group includes all patients consented to participate in this study.
Period Title: Overall Study
Started 14
Completed 12
Not Completed 2
Reason Not Completed
Death             1
Treating physician decision             1
Arm/Group Title All Patients Enrolled
Hide Arm/Group Description This group includes all patients consented to participate in this study.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
55  (5.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
Hide Description Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.
Time Frame Day 12-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ovarian/Fallopian Tube/Peritoneal Cancer Patients
Hide Arm/Group Description:
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Patients
0
2.Secondary Outcome
Title Number of Patients Per Disease Response
Hide Description Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion.
Time Frame 1 Month After Natural Killer Cell Infusion (Day 30)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes 12 patients that completed treatment per protocol criteria.
Arm/Group Title No Total Body Irradiation Total Body Irradiation
Hide Arm/Group Description:
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
Overall Number of Participants Analyzed 7 5
Measure Type: Number
Unit of Measure: Patients
Complete Response 0 0
Partial Response 2 1
Stable Disease 4 4
Progressive Disease 1 0
3.Secondary Outcome
Title Median Number of Days to Progression
Hide Description Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions.
Time Frame From date of first treatment to disease progression
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Total Body Irradiation Total Body Irradiation
Hide Arm/Group Description:
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
Overall Number of Participants Analyzed 7 5
Median (95% Confidence Interval)
Unit of Measure: Days
107
(8 to 200)
90
(69 to 130)
4.Secondary Outcome
Title Median Overall Survival Number of Days Patients Alive After Treatment
Hide Description Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
Time Frame From first date on-study (treatment) to date of death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Body Irradiation No Total Body Irradiation
Hide Arm/Group Description:
This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
Overall Number of Participants Analyzed 5 7
Median (95% Confidence Interval)
Unit of Measure: Days
171.5
(144 to 199)
291
(8 to 301)
Time Frame Serious adverse events were monitored through the follow-up period; death was followed for up to 2 years after Day 1 treatment.
Adverse Event Reporting Description Adverse event collection for the purposes of this study focused on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL-2 injections.
 
Arm/Group Title All Patients Enrolled
Hide Arm/Group Description This group includes all patients consented to participate in this study.
All-Cause Mortality
All Patients Enrolled
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients Enrolled
Affected / at Risk (%) # Events
Total   9/14 (64.29%)    
Blood and lymphatic system disorders   
Hemolysis  1 [1]  1/14 (7.14%)  1
Cardiac disorders   
Left ventricular systolic dysfunction  1  1/14 (7.14%)  1
Gastrointestinal disorders   
Pain - abdomen NOS  1  1/14 (7.14%)  1
General disorders   
Constitutional symptoms  1  1/14 (7.14%)  2
Death - disease progression NOS  1  5/14 (35.71%)  5
Tumor lysis syndrome  1  1/14 (7.14%)  1
Infections and infestations   
Infection  1  1/14 (7.14%)  1
Infection - febrile neutropenia  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration  1  1/14 (7.14%)  1
Hypoxia  1  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
immune hemolytic anemia, drug-related hemolysis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients Enrolled
Affected / at Risk (%) # Events
Total   13/14 (92.86%)    
Blood and lymphatic system disorders   
Edema  1  6/14 (42.86%)  29
Positive blood culture with fever  1  2/14 (14.29%)  5
Hemolysis  1  1/14 (7.14%)  1
Cardiac disorders   
Hypertension  1  1/14 (7.14%)  8
Gastrointestinal disorders   
Vomiting  1  11/14 (78.57%)  30
Nausea  1  12/14 (85.71%)  80
General disorders   
Fever  1  12/14 (85.71%)  42
Chills  1  12/14 (85.71%)  44
Fatigue  1  13/14 (92.86%)  115
Musculoskeletal and connective tissue disorders   
Myalgia  1  9/14 (64.29%)  28
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  6/14 (42.86%)  23
Pneumonia  1  3/14 (21.43%)  17
Cough  1  5/14 (35.71%)  18
Skin and subcutaneous tissue disorders   
Injection Site Reaction  1  11/14 (78.57%)  58
Rash  1  11/14 (78.57%)  45
Sweats  1  10/14 (71.43%)  27
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)

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.

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
ClinicalTrials.gov 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