Trial Outcomes & Findings for Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer (NCT NCT00376805)
NCT ID: NCT00376805
Last Updated: 2017-12-28
Results Overview
Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of \>100 cells/ul of whole blood 14 days after infusion with \<5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Day 14
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
NK Cells With or Without Total Body Irradiation
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 Participants
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of \>100 cells/ul of whole blood 14 days after infusion with \<5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).
Outcome measures
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 Participants
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Number of Patients Who Had Expansion of Natural Killer Cells
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 Months, 1 YearDefined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria: * Complete Response (CR: Disappearance of all target lesions * Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD * Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions of clinical benefit (CB; stable disease for greater than 6 months.
Outcome measures
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 Participants
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Number of Patients by Disease Response
Stable Disease
|
4 Participants
|
|
Number of Patients by Disease Response
Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 100 days, After 100 daysNumber of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.
Outcome measures
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 Participants
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Number of Patients Who Died While on Study
Died within 100 days
|
1 Participants
|
|
Number of Patients Who Died While on Study
Died after 100 days
|
5 Participants
|
SECONDARY outcome
Timeframe: First Day of Treatment Until DeathCalculated median number of days of survival (patients alive days after treatment).
Outcome measures
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 Participants
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Overall Median Number of Days Patients Alive After Treatment
|
124 Days
Interval 55.0 to 212.0
|
Adverse Events
NK Cells With or Without Total Body Irradiation
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 participants at risk
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
General disorders
Death - disease progression NOS
|
50.0%
3/6 • Number of events 3 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
General disorders
Death due to progressive disease
|
50.0%
3/6 • Number of events 3 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Blood and lymphatic system disorders
Passenger lymphocyte syndrome
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
Other adverse events
| Measure |
NK Cells With or Without Total Body Irradiation
n=6 participants at risk
Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 11 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 6 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
General disorders
Fever
|
100.0%
6/6 • Number of events 26 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
General disorders
Chills
|
100.0%
6/6 • Number of events 19 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Cardiac disorders
Hypertension
|
33.3%
2/6 • Number of events 12 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Cardiac disorders
Hypotension
|
16.7%
1/6 • Number of events 2 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
General disorders
Fatigue
|
100.0%
6/6 • Number of events 46 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Blood and lymphatic system disorders
Edema
|
66.7%
4/6 • Number of events 22 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
3/6 • Number of events 15 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
100.0%
6/6 • Number of events 26 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
83.3%
5/6 • Number of events 30 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 3 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 6 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 11 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
4/6 • Number of events 16 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Skin and subcutaneous tissue disorders
Sweats
|
66.7%
4/6 • Number of events 16 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 10 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Nervous system disorders
Anxiety
|
16.7%
1/6 • Number of events 3 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Cardiac disorders
Cardiac function LVEF
|
16.7%
1/6 • Number of events 3 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
16.7%
1/6 • Number of events 1 • All adverse events were collected up to patients' death (within 1 year of treatment).
|
Additional Information
Sarah Cooley, MD
Masonic Cancer Center, University of Minnesota
Phone: 612-625-8474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place