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Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01105650
Recruitment Status : Completed
First Posted : April 16, 2010
Results First Posted : February 24, 2017
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: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Breast Cancer
Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Cyclosporine
Biological: Natural killer cells
Drug: IL-2
Drug: Methylprednisolone
Drug: Interleukin-2

  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
Up to 4 sequential immunosuppressive platforms (study arms) were tested to identify a platform where patients have the potential for successful Natural Killer (NK) cell expansion (defined as an absolute circulating donor derived NK cell count of > 100 cells/μl 14 days after NK cell infusion).

Reporting Groups
  Description
Arm 1: CsA

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9
Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m^2 3 times per week for 3 doses).

Participant Flow:   Overall Study
    Arm 1: CsA   Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2   Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2   Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2
STARTED   3   3   7   0 [1] 
COMPLETED   3   3   7   0 
NOT COMPLETED   0   0   0   0 
[1] Arm 3 was determined to be successful, thus eliminating the need to test Arm 4.



  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
Arm 1: CsA

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9
Total Total of all reporting groups

Baseline Measures
   Arm 1: CsA   Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2   Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 3   3   7   13 
Age 
[Units: Participants]
Count of Participants 		       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      2  66.7%      5  71.4%      7  53.8% 
>=65 years      3 100.0%      1  33.3%      2  28.6%      6  46.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      3 100.0%      3 100.0%      7 100.0%      13 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Month 3 ]
  Show Outcome Measure 1

2.  Secondary:   Time to Disease Progression   [ Time Frame: 1 Year ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Progressive Disease at One Year   [ Time Frame: 1 Year ]
  Show Outcome Measure 3

4.  Secondary:   Overall Survival   [ Time Frame: 1 Year ]
  Show Outcome Measure 4


  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
No text entered.


  More Information

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.


Results Point of Contact:  
Name/Title: Dr. Melissa Geller
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-3111
e-mail: gelle005@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01105650     History of Changes
Other Study ID Numbers: 2009LS142
MT2009-30 ( Other Identifier: Blood and Marrow Transplantation Program )
1003M78876 ( Other Identifier: IRB, University of Minnesota )
First Submitted: April 14, 2010
First Posted: April 16, 2010
Results First Submitted: January 4, 2017
Results First Posted: February 24, 2017
Last Update Posted: December 28, 2017