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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
Enrollment 13

Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title 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
Hide Arm/Group Description

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).

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.

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

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).

Period Title: Overall Study
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.
Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2 Total
Hide Arm/Group Description

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).

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.

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 of all reporting groups
Overall Number of Baseline Participants 3 3 7 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 7 participants 13 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 7 participants 13 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%
1.Primary Outcome
Title Response Rate
Hide Description Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
Time Frame Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Hide Arm/Group Description:

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).

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.

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

Overall Number of Participants Analyzed 3 3 7
Measure Type: Number
Unit of Measure: participants
1 2 4
2.Secondary Outcome
Title Time to Disease Progression
Hide Description Time from study entry until progressive disease or data collection cutoff.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Number of participants with progressive disease at one year:

Arm 1: 2 out of 3; Arm 2: 1 out of 3; Arm 3: 5 out of 7

Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Hide Arm/Group Description:

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).

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.

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

Overall Number of Participants Analyzed 3 3 7
Median (Full Range)
Unit of Measure: days
52
(28 to 76)
98
(98 to 98)
100
(94 to 201)
3.Secondary Outcome
Title Number of Participants With Progressive Disease at One Year
Hide Description [Not Specified]
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Hide Arm/Group Description:

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).

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.

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

Overall Number of Participants Analyzed 3 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
1
  33.3%
5
  71.4%
4.Secondary Outcome
Title Overall Survival
Hide Description Number of participants alive at 1 year.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Hide Arm/Group Description:

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).

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.

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

Overall Number of Participants Analyzed 3 3 7
Measure Type: Number
Unit of Measure: participants
0 1 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Hide Arm/Group Description

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).

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.

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

All-Cause Mortality
Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   5/7 (71.43%) 
Cardiac disorders       
Atrial flutter  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Ear and labyrinth disorders       
Hearing impairmed  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Vestibular disorder  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Eye disorders       
Blurred vision  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1/3 (33.33%)  0/3 (0.00%)  0/7 (0.00%) 
General disorders       
Death NOS  3/3 (100.00%)  2/3 (66.67%)  1/7 (14.29%) 
Fever  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Renal and urinary disorders       
Acute kidney injury  0/3 (0.00%)  1/3 (33.33%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1/3 (33.33%)  0/3 (0.00%)  0/7 (0.00%) 
Respiratory failure  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Vascular disorders       
Hypertension  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: CsA Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2 Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders       
Neutropenic fever  1/3 (33.33%)  3/3 (100.00%)  6/7 (85.71%) 
Cardiac disorders       
Atrial fibrillation  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Ear and labyrinth disorders       
Hearing loss  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Eye disorders       
Double vision  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Gastrointestinal disorders       
Ascites  2/3 (66.67%)  1/3 (33.33%)  0/7 (0.00%) 
Nausea  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Pain with stools  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
General disorders       
Chills  3/3 (100.00%)  3/3 (100.00%)  7/7 (100.00%) 
Edema  2/3 (66.67%)  3/3 (100.00%)  5/7 (71.43%) 
Fever  3/3 (100.00%)  2/3 (66.67%)  6/7 (85.71%) 
Infusion related reaction  2/3 (66.67%)  0/3 (0.00%)  3/7 (42.86%) 
Injection Site Reaction  1/3 (33.33%)  0/3 (0.00%)  5/7 (71.43%) 
Body aches  0/3 (0.00%)  0/3 (0.00%)  2/7 (28.57%) 
Night sweats  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications       
Fall  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Investigations       
Creatinine Increased  0/3 (0.00%)  0/3 (0.00%)  4/7 (57.14%) 
Weight gain  0/3 (0.00%)  0/3 (0.00%)  3/7 (42.86%) 
Metabolism and nutrition disorders       
Hypokalemia  0/3 (0.00%)  0/3 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders       
Foot pain  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Nervous system disorders       
Headache  1/3 (33.33%)  1/3 (33.33%)  4/7 (57.14%) 
Depressed level of consciousness  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Hallucinations  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Dizziness  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Confusion/Disoriented  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Strange dreams  0/3 (0.00%)  1/3 (33.33%)  0/7 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1/3 (33.33%)  1/3 (33.33%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  3/3 (100.00%)  3/3 (100.00%)  5/7 (71.43%) 
Hypoxia  3/3 (100.00%)  2/3 (66.67%)  4/7 (57.14%) 
Pleural effusion  2/3 (66.67%)  0/3 (0.00%)  0/7 (0.00%) 
Pneumonitis/Pulmonary Infiltrates  1/3 (33.33%)  0/3 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders       
Rash/Desquamation  2/3 (66.67%)  1/3 (33.33%)  2/7 (28.57%) 
Vascular disorders       
Capillary leak syndrome  2/3 (66.67%)  0/3 (0.00%)  3/7 (42.86%) 
Hypertension  3/3 (100.00%)  2/3 (66.67%)  7/7 (100.00%) 
Hypotension  0/3 (0.00%)  2/3 (66.67%)  3/7 (42.86%) 
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
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