Trial Outcomes & Findings for Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma (NCT NCT00513604)
NCT ID: NCT00513604
Last Updated: 2013-06-03
Results Overview
Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012
Results posted on
2013-06-03
Participant Flow
Note with amendment K patients cohorts 1-3 were closed and patients were randomized between cohorts 4 and 5. The difference in the cohorts is NOT aldesleukin. The aldesleukin, cyclophosphamide and fludarabine are the same for each cohort. The difference is in the TIL and in cohort 3, the addition of radiation.
Participant milestones
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
39
|
24
|
34
|
35
|
|
Overall Study
COMPLETED
|
24
|
36
|
21
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Overall Study
Not treated
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Death during treatment
|
0
|
3
|
2
|
0
|
0
|
Baseline Characteristics
Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
n=26 Participants
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
n=39 Participants
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
n=24 Participants
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
n=34 Participants
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
n=35 Participants
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
157 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age Continuous
|
48.8 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
46.3 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
43.2 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
45.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 12.0 • n=31 Participants
|
45.4 years
STANDARD_DEVIATION 11.9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
72 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
86 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
158 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
158 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
39 participants
n=107 Participants
|
24 participants
n=206 Participants
|
34 participants
n=7 Participants
|
35 participants
n=31 Participants
|
158 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
n=26 Participants
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
n=39 Participants
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
n=24 Participants
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
n=34 Participants
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
n=35 Participants
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Clinical Response
Complete Response
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Clinical Response
Partial Response
|
3 Participants
|
18 Participants
|
7 Participants
|
10 Participants
|
4 Participants
|
|
Clinical Response
Progression
|
20 Participants
|
16 Participants
|
12 Participants
|
21 Participants
|
24 Participants
|
|
Clinical Response
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Clinical Response
Not evaluable - cell product did not grow
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Not evaluable-toxicities re:disease/death
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Not evaluable - Patient died of sepsis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 yearsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
n=26 Participants
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
n=39 Participants
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
n=24 Participants
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
n=34 Participants
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
n=35 Participants
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Toxicity
|
24 Participants
|
39 Participants
|
23 Participants
|
34 Participants
|
35 Participants
|
Adverse Events
Cohort 1 - NMA, TIL, Aldesleukin
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 3 - NMA, Total Body Irradiation
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 4 - NMA, Young TIL, Aldesleukin
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
n=26 participants at risk
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
n=39 participants at risk
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
n=24 participants at risk
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
n=34 participants at risk
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
n=35 participants at risk
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
2/26 • Number of events 2
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Eye disorders
Blurred vision
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Ileal perforation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
General disorders
Multi-organ failure
|
3.8%
1/26 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.7%
2/26 • Number of events 2
|
0.00%
0/39
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Leukoencephalopathy
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Somnolence
|
7.7%
2/26 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
2/26 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
19.2%
5/26 • Number of events 5
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Vascular disorders
Thromboembolic event
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
General disorders
Death NOS
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Infections and infestations
Lung infection
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders _ Other, specify
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Investigations
Platelet count decreased
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
General disorders
Fatigue
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 2
|
0.00%
0/35
|
|
General disorders
Fever
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1 - NMA, TIL, Aldesleukin
n=26 participants at risk
Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), \& high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 2 - NMA, CD4+ TIL, Aldesleukin
n=39 participants at risk
Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 3 - NMA, Total Body Irradiation
n=24 participants at risk
Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):
Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 4 - NMA, Young TIL, Aldesleukin
n=34 participants at risk
Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days.
|
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
n=35 participants at risk
Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:
Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.
Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m\^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
57.7%
15/26 • Number of events 17
|
69.2%
27/39 • Number of events 32
|
83.3%
20/24 • Number of events 23
|
32.4%
11/34 • Number of events 14
|
51.4%
18/35 • Number of events 21
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
38.5%
10/26 • Number of events 10
|
43.6%
17/39 • Number of events 17
|
45.8%
11/24 • Number of events 11
|
41.2%
14/34 • Number of events 14
|
45.7%
16/35 • Number of events 16
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
2/26 • Number of events 3
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
0.00%
0/35
|
|
Cardiac disorders
Sinus tachycardia
|
15.4%
4/26 • Number of events 4
|
0.00%
0/39
|
0.00%
0/24
|
8.8%
3/34 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3
|
7.7%
3/39 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
11.4%
4/35 • Number of events 4
|
|
General disorders
Chills
|
15.4%
4/26 • Number of events 4
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
General disorders
Fatigue
|
15.4%
4/26 • Number of events 4
|
35.9%
14/39 • Number of events 17
|
37.5%
9/24 • Number of events 10
|
23.5%
8/34 • Number of events 8
|
28.6%
10/35 • Number of events 10
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Immune system disorders
Allergic reaction
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Catheter-related infection
|
3.8%
1/26 • Number of events 1
|
10.3%
4/39 • Number of events 5
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.5%
3/26 • Number of events 3
|
25.6%
10/39 • Number of events 11
|
25.0%
6/24 • Number of events 7
|
20.6%
7/34 • Number of events 7
|
22.9%
8/35 • Number of events 8
|
|
Investigations
Activated partial thromboplastin time prolonged
|
15.4%
4/26 • Number of events 4
|
5.1%
2/39 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Number of events 1
|
10.3%
4/39 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
5.7%
2/35 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
7.7%
2/26 • Number of events 2
|
12.8%
5/39 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
8.6%
3/35 • Number of events 3
|
|
Investigations
Creatinine increased
|
15.4%
4/26 • Number of events 4
|
7.7%
3/39 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
Investigations
Electrocardiogram QT corrected interval prolong
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Investigations
Lymphocyte count decreased
|
92.3%
24/26 • Number of events 27
|
92.3%
36/39 • Number of events 40
|
95.8%
23/24 • Number of events 26
|
100.0%
34/34 • Number of events 37
|
100.0%
35/35 • Number of events 36
|
|
Investigations
Neutrophil count decreased
|
92.3%
24/26 • Number of events 26
|
92.3%
36/39 • Number of events 41
|
95.8%
23/24 • Number of events 25
|
97.1%
33/34 • Number of events 34
|
100.0%
35/35 • Number of events 35
|
|
Investigations
Platelet count decreased
|
80.8%
21/26 • Number of events 22
|
87.2%
34/39 • Number of events 37
|
95.8%
23/24 • Number of events 24
|
94.1%
32/34 • Number of events 32
|
88.6%
31/35 • Number of events 31
|
|
Investigations
Urine output decreased
|
19.2%
5/26 • Number of events 5
|
5.1%
2/39 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
|
Investigations
White blood cell decreased
|
53.8%
14/26 • Number of events 26
|
92.3%
36/39 • Number of events 37
|
91.7%
22/24 • Number of events 22
|
97.1%
33/34 • Number of events 33
|
100.0%
35/35 • Number of events 35
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.8%
1/26 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.4%
4/26 • Number of events 4
|
12.8%
5/39 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
53.8%
14/26 • Number of events 14
|
25.6%
10/39 • Number of events 11
|
20.8%
5/24 • Number of events 5
|
20.6%
7/34 • Number of events 8
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.2%
5/26 • Number of events 7
|
10.3%
4/39 • Number of events 4
|
16.7%
4/24 • Number of events 5
|
11.8%
4/34 • Number of events 5
|
11.4%
4/35 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.9%
7/26 • Number of events 9
|
10.3%
4/39 • Number of events 5
|
0.00%
0/24
|
5.9%
2/34 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.8%
8/26 • Number of events 8
|
7.7%
3/39 • Number of events 3
|
12.5%
3/24 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
34.6%
9/26 • Number of events 9
|
17.9%
7/39 • Number of events 9
|
29.2%
7/24 • Number of events 8
|
29.4%
10/34 • Number of events 10
|
14.3%
5/35 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1
|
7.7%
3/39 • Number of events 3
|
16.7%
4/24 • Number of events 4
|
0.00%
0/34
|
5.7%
2/35 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 2
|
0.00%
0/35
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1
|
28.2%
11/39 • Number of events 12
|
16.7%
4/24 • Number of events 4
|
5.9%
2/34 • Number of events 3
|
11.4%
4/35 • Number of events 4
|
|
Nervous system disorders
peripheral sensory neuropathy
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
|
Psychiatric disorders
Confusion
|
26.9%
7/26 • Number of events 7
|
23.1%
9/39 • Number of events 9
|
25.0%
6/24 • Number of events 6
|
20.6%
7/34 • Number of events 7
|
5.7%
2/35 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4
|
5.1%
2/39 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.2%
12/26 • Number of events 12
|
74.4%
29/39 • Number of events 29
|
45.8%
11/24 • Number of events 13
|
52.9%
18/34 • Number of events 18
|
25.7%
9/35 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
19.2%
5/26 • Number of events 6
|
43.6%
17/39 • Number of events 17
|
16.7%
4/24 • Number of events 4
|
26.5%
9/34 • Number of events 9
|
17.1%
6/35 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.8%
1/26 • Number of events 1
|
23.1%
9/39 • Number of events 9
|
16.7%
4/24 • Number of events 4
|
0.00%
0/34
|
0.00%
0/35
|
|
Vascular disorders
Capillary leak syndrome
|
38.5%
10/26 • Number of events 10
|
17.9%
7/39 • Number of events 7
|
8.3%
2/24 • Number of events 4
|
20.6%
7/34 • Number of events 7
|
5.7%
2/35 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Number of events 4
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
8.8%
3/34 • Number of events 3
|
11.4%
4/35 • Number of events 4
|
|
Vascular disorders
Thromboembolic event
|
3.8%
1/26 • Number of events 1
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders _ Other, specify
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Cardiac disorders
Palpitations
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Eye disorders
Flashing lights
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
20.5%
8/39 • Number of events 8
|
8.3%
2/24 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
16.7%
4/24 • Number of events 4
|
8.8%
3/34 • Number of events 3
|
0.00%
0/35
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Bladder infection
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Lung infection
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Ataxia
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26
|
10.3%
4/39 • Number of events 4
|
12.5%
3/24 • Number of events 3
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Psychiatric disorders
Agitation
|
0.00%
0/26
|
7.7%
3/39 • Number of events 3
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/26
|
33.3%
13/39 • Number of events 15
|
33.3%
8/24 • Number of events 9
|
20.6%
7/34 • Number of events 7
|
14.3%
5/35 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/26
|
7.7%
3/39 • Number of events 3
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/26
|
10.3%
4/39 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodyesthesia syndrome
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/26
|
41.0%
16/39 • Number of events 17
|
45.8%
11/24 • Number of events 11
|
17.6%
6/34 • Number of events 6
|
8.6%
3/35 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Vascular disorders
Hypertension
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Eye disorders
Blurred vision
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Infections and infestations
Sepsis
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
5.7%
2/35 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/26
|
0.00%
0/39
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Eye disorders
Retinopathy
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26
|
10.3%
4/39 • Number of events 4
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/26
|
2.6%
1/39 • Number of events 2
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/26
|
7.7%
3/39 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/26
|
5.1%
2/39 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Psychiatric disorders
Depression
|
0.00%
0/26
|
2.6%
1/39 • Number of events 1
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/26
|
0.00%
0/39
|
4.2%
1/24 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.9%
1/35 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/26
|
0.00%
0/39
|
8.3%
2/24 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
|
General disorders
Injection site reaction
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Nervous system disorders
Syncope
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Investigations
Weight gain
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26
|
0.00%
0/39
|
0.00%
0/24
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
Additional Information
Dr. Steven Rosenberg
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