Trial Outcomes & Findings for Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer (NCT NCT01105650)
NCT ID: NCT01105650
Last Updated: 2017-12-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Month 3
Results posted on
2017-12-28
Participant Flow
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).
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: CsA
n=3 Participants
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
n=3 Participants
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
n=7 Participants
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
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 3Response 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.
Outcome measures
| Measure |
Arm 1: CsA
n=3 Participants
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
n=3 Participants
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
n=7 Participants
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
|
|---|---|---|---|
|
Response Rate
|
1 participants
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: 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
Time from study entry until progressive disease or data collection cutoff.
Outcome measures
| Measure |
Arm 1: CsA
n=3 Participants
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
n=3 Participants
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
n=7 Participants
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
|
|---|---|---|---|
|
Time to Disease Progression
|
52 days
Interval 28.0 to 76.0
|
98 days
Interval 98.0 to 98.0
|
100 days
Interval 94.0 to 201.0
|
SECONDARY outcome
Timeframe: 1 YearOutcome measures
| Measure |
Arm 1: CsA
n=3 Participants
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
n=3 Participants
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
n=7 Participants
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
|
|---|---|---|---|
|
Number of Participants With Progressive Disease at One Year
|
2 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 YearNumber of participants alive at 1 year.
Outcome measures
| Measure |
Arm 1: CsA
n=3 Participants
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
n=3 Participants
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
n=7 Participants
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 Survival
|
0 participants
|
1 participants
|
3 participants
|
Adverse Events
Arm 1: CsA
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: CsA
n=3 participants at risk
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
n=3 participants at risk
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
n=7 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/7
|
|
General disorders
Death NOS
|
100.0%
3/3
|
66.7%
2/3
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Hearing impairmed
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Eye disorders
Blurred vision
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3
|
33.3%
1/3
|
14.3%
1/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
Other adverse events
| Measure |
Arm 1: CsA
n=3 participants at risk
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
n=3 participants at risk
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
n=7 participants at risk
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
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3
|
33.3%
1/3
|
14.3%
1/7
|
|
Gastrointestinal disorders
Ascites
|
66.7%
2/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Vascular disorders
Capillary leak syndrome
|
66.7%
2/3
|
0.00%
0/3
|
42.9%
3/7
|
|
General disorders
Chills
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
7/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
3/3
|
100.0%
3/3
|
71.4%
5/7
|
|
General disorders
Edema
|
66.7%
2/3
|
100.0%
3/3
|
71.4%
5/7
|
|
General disorders
Fever
|
100.0%
3/3
|
66.7%
2/3
|
85.7%
6/7
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
33.3%
1/3
|
57.1%
4/7
|
|
Vascular disorders
Hypertension
|
100.0%
3/3
|
66.7%
2/3
|
100.0%
7/7
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
3/3
|
66.7%
2/3
|
57.1%
4/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
66.7%
2/3
|
0.00%
0/3
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
66.7%
2/3
|
33.3%
1/3
|
28.6%
2/7
|
|
General disorders
Infusion related reaction
|
66.7%
2/3
|
0.00%
0/3
|
42.9%
3/7
|
|
General disorders
Injection Site Reaction
|
33.3%
1/3
|
0.00%
0/3
|
71.4%
5/7
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
33.3%
1/3
|
100.0%
3/3
|
85.7%
6/7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates
|
33.3%
1/3
|
0.00%
0/3
|
14.3%
1/7
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
66.7%
2/3
|
42.9%
3/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Nervous system disorders
Confusion/Disoriented
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Eye disorders
Double vision
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Nervous system disorders
Strange dreams
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/7
|
|
Investigations
Creatinine Increased
|
0.00%
0/3
|
0.00%
0/3
|
57.1%
4/7
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
General disorders
Body aches
|
0.00%
0/3
|
0.00%
0/3
|
28.6%
2/7
|
|
General disorders
Night sweats
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
Investigations
Weight gain
|
0.00%
0/3
|
0.00%
0/3
|
42.9%
3/7
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
|
Gastrointestinal disorders
Pain with stools
|
0.00%
0/3
|
0.00%
0/3
|
14.3%
1/7
|
Additional Information
Dr. Melissa Geller
Masonic Cancer Center, University of Minnesota
Phone: 612-626-3111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place