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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT01105650

First received: April 14, 2010

Last updated: February 27, 2017

Last verified: February 2016

History of Changes

Results First Received: January 4, 2017

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

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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
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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

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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.
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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

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1. Primary:

Response Rate [ Time Frame: Month 3 ]

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2. Secondary:

Time to Disease Progression [ Time Frame: 1 Year ]

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3. Secondary:

Number of Participants With Progressive Disease at One Year [ Time Frame: 1 Year ]

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4. Secondary:

Overall Survival [ Time Frame: 1 Year ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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.

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 )
Study First Received:	April 14, 2010
Results First Received:	January 4, 2017
Last Updated:	February 27, 2017

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