Trial Outcomes & Findings for Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer (NCT NCT00328861)
NCT ID: NCT00328861
Last Updated: 2012-11-05
Results Overview
Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
Results posted on
2012-11-05
Participant Flow
Participant milestones
| Measure |
NK Cells + IL-2: Melanoma
Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
NK Cells + IL-2: Renal Cell
Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
|
Overall Study
COMPLETED
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer
Baseline characteristics by cohort
| Measure |
NK Cells + IL-2: Melanoma
n=7 Participants
Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
NK Cells + IL-2: Renal Cell
n=1 Participants
Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
Total
n=8 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
37.3 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 0 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
NK Cells + IL-2: Melanoma
n=7 Participants
Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
NK Cells + IL-2: Renal Cell
n=1 Participants
Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
|---|---|---|
|
Objective Response
Complete Response
|
0 Participants
|
0 Participants
|
|
Objective Response
Partial Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 11/30/2006 - 7/31/2007Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
NK Cells + IL-2: Melanoma
n=7 Participants
Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
NK Cells + IL-2: Renal Cell
n=1 Participants
Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
|---|---|---|
|
Safety
|
7 Participants
|
1 Participants
|
Adverse Events
NK Cells + IL-2: Melanoma
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
NK Cells + IL-2: Renal Cell
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NK Cells + IL-2: Melanoma
n=7 participants at risk
Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
NK Cells + IL-2: Renal Cell
n=1 participants at risk
Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m\^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
100.0%
7/7 • Number of events 7
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
7/7 • Number of events 12
|
100.0%
1/1 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
100.0%
7/7 • Number of events 7
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
7/7 • Number of events 7
|
100.0%
1/1 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
14.3%
1/7 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Fatigue
|
85.7%
6/7 • Number of events 8
|
100.0%
1/1 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Number of events 8
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Petechiae
|
57.1%
4/7 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/7
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
57.1%
4/7 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
14.3%
1/7 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Confusion
|
42.9%
3/7 • Number of events 4
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7
|
100.0%
1/1 • Number of events 3
|
|
Vascular disorders
Capillary leak syndrome
|
71.4%
5/7 • Number of events 6
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
42.9%
3/7 • Number of events 3
|
0.00%
0/1
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Cardiac disorders
Premature ventricular contractions
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Fever
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
General disorders
General symptom
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
1/7 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 2
|
0.00%
0/1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
28.6%
2/7 • Number of events 3
|
0.00%
0/1
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • Number of events 2
|
0.00%
0/1
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Infections and infestations
Wound infection
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
42.9%
3/7 • Number of events 3
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
General disorders
Pain in extremity
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
57.1%
4/7 • Number of events 7
|
0.00%
0/1
|
|
Nervous system disorders
Neuralgia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • Number of events 5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/1
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place