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Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00513604
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : May 27, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Melanoma
Malignant Melanoma
Melanoma, Experimental
Experimental Melanomas
Interventions Biological: aldesleukin
Biological: therapeutic autologous lymphocytes
Drug: Cyclophosphamide
Drug: Fludarabine phosphate
Radiation: Total body irradiation
Enrollment 158
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Hide Arm/Group Description

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 - 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 - 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 - 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 - 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

Period Title: Overall Study
Started 26 [1] 39 [2] 24 [3] 34 [4] 35 [5]
Completed 24 36 21 34 35
Not Completed 2 3 3 0 0
Reason Not Completed
Not treated             2             0             1             0             0
Death during treatment             0             3             2             0             0
[1]
Cohort 1 = unselected TIL
[2]
Cohort 2 = CD4+ depleted (selected) TIL
[3]
Cohort 3 = CD4+ depleted (selected) TIL + 600Gy radiation
[4]
Cohort 4 = unselected TIL - it is the SAME as cohort 1
[5]
Cohort 5 = CD4+ depleted TIL-it is the SAME as cohort 2
Arm/Group Title Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin Total
Hide Arm/Group Description

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 - 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 - 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 - 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 - 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 of all reporting groups
Overall Number of Baseline Participants 26 39 24 34 35 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
1
   0.6%
Between 18 and 65 years
26
 100.0%
39
 100.0%
24
 100.0%
34
 100.0%
34
  97.1%
157
  99.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
48.8  (13.7) 46.3  (11.0) 43.2  (11.9) 45.1  (11.3) 43.9  (12.0) 45.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
Female
10
  38.5%
22
  56.4%
11
  45.8%
11
  32.4%
18
  51.4%
72
  45.6%
Male
16
  61.5%
17
  43.6%
13
  54.2%
23
  67.6%
17
  48.6%
86
  54.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
26
 100.0%
39
 100.0%
24
 100.0%
34
 100.0%
35
 100.0%
158
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
26
 100.0%
39
 100.0%
24
 100.0%
34
 100.0%
35
 100.0%
158
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 39 participants 24 participants 34 participants 35 participants 158 participants
26 39 24 34 35 158
1.Primary Outcome
Title Clinical Response
Hide Description 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.
Time Frame every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Hide Arm/Group Description:

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 - 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 - 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 - 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 - 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 Number of Participants Analyzed 26 39 24 34 35
Measure Type: Number
Unit of Measure: Participants
Complete Response 1 3 3 2 3
Partial Response 3 18 7 10 4
Progression 20 16 12 21 24
Stable Disease 0 0 0 1 4
Not evaluable - cell product did not grow 2 0 1 0 0
Not evaluable-toxicities re:disease/death 0 2 0 0 0
Not evaluable - Patient died of sepsis 0 0 1 0 0
2.Primary Outcome
Title Toxicity
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Hide Arm/Group Description:

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 - 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 - 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 - 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 - 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 Number of Participants Analyzed 26 39 24 34 35
Measure Type: Number
Unit of Measure: Participants
24 39 23 34 35
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Hide Arm/Group Description

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 - 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 - 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 - 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 - 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

All-Cause Mortality
Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/26 (34.62%)      8/39 (20.51%)      5/24 (20.83%)      5/34 (14.71%)      4/35 (11.43%)    
Blood and lymphatic system disorders           
Febrile neutropenia  1  2/26 (7.69%)  2 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Blood and lymphatic system disorders _ Other, specify  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Cardiac disorders           
Atrial fibrillation  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Supraventricular tachycardia  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Eye disorders           
Blurred vision  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders           
Ileal perforation  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Nausea  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
General disorders           
Multi-organ failure  1  1/26 (3.85%)  1 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Death NOS  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Fatigue  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  2 0/35 (0.00%)  0
Fever  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Infections and infestations           
Infections and infestations - Other, specify  1  2/26 (7.69%)  2 0/39 (0.00%)  0 2/24 (8.33%)  2 0/34 (0.00%)  0 0/35 (0.00%)  0
Lung infection  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Investigations           
Platelet count decreased  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Metabolism and nutrition disorders           
Anorexia  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Generalized muscle weakness  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Arthralgia  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Pain in extremity  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumor pain  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders           
Leukoencephalopathy  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Peripheral motor neuropathy  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Somnolence  1  2/26 (7.69%)  2 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Intracranial hemorrhage  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Psychiatric disorders           
Confusion  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  2/26 (7.69%)  2 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Dyspnea  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Hypoxia  1  5/26 (19.23%)  5 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders           
Hypotension  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Thromboembolic event  1  1/26 (3.85%)  1 0/39 (0.00%)  0 1/24 (4.17%)  1 1/34 (2.94%)  1 2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 - NMA, TIL, Aldesleukin Cohort 2 - NMA, CD4+ TIL, Aldesleukin Cohort 3 - NMA, Total Body Irradiation Cohort 4 - NMA, Young TIL, Aldesleukin Cohort 5 - NMA, CD4+TIL, HD Aldesleukin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/26 (92.31%)      39/39 (100.00%)      23/24 (95.83%)      34/34 (100.00%)      35/35 (100.00%)    
Blood and lymphatic system disorders           
Anemia  1  15/26 (57.69%)  17 27/39 (69.23%)  32 20/24 (83.33%)  23 11/34 (32.35%)  14 18/35 (51.43%)  21
Febrile neutropenia  1  10/26 (38.46%)  10 17/39 (43.59%)  17 11/24 (45.83%)  11 14/34 (41.18%)  14 16/35 (45.71%)  16
Blood and lymphatic system disorders _ Other, specify  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Disseminated intravascular coagulation  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Hemolysis  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Cardiac disorders           
Atrial fibrillation  1  2/26 (7.69%)  3 0/39 (0.00%)  0 1/24 (4.17%)  1 2/34 (5.88%)  2 0/35 (0.00%)  0
Sinus tachycardia  1  4/26 (15.38%)  4 0/39 (0.00%)  0 0/24 (0.00%)  0 3/34 (8.82%)  3 1/35 (2.86%)  1
Palpitations  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Paroxysmal atrial tachycardia  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Ventricular arrhythmia  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Ear and labyrinth disorders           
Hearing impaired  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Tinnitus  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Eye disorders           
Flashing lights  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Blurred vision  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Extraocular muscle paresis  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Retinopathy  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Gastrointestinal disorders           
Ascites  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Diarrhea  1  3/26 (11.54%)  3 3/39 (7.69%)  3 2/24 (8.33%)  2 2/34 (5.88%)  2 4/35 (11.43%)  4
Abdominal distention  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Abdominal pain  1  0/26 (0.00%)  0 8/39 (20.51%)  8 2/24 (8.33%)  2 3/34 (8.82%)  3 1/35 (2.86%)  1
Dysphagia  1  0/26 (0.00%)  0 1/39 (2.56%)  1 1/24 (4.17%)  1 1/34 (2.94%)  1 0/35 (0.00%)  0
Esophagitis  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Hemorrhoids  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Nausea  1  0/26 (0.00%)  0 1/39 (2.56%)  1 4/24 (16.67%)  4 3/34 (8.82%)  3 0/35 (0.00%)  0
Typhlitis  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Rectal hemorrhage  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Vomiting  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 1/34 (2.94%)  1 0/35 (0.00%)  0
Anal pain  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
General disorders           
Chills  1  4/26 (15.38%)  4 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Fatigue  1  4/26 (15.38%)  4 14/39 (35.90%)  17 9/24 (37.50%)  10 8/34 (23.53%)  8 10/35 (28.57%)  10
Pain  1  1/26 (3.85%)  1 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Fever  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Non-cardiac chest pain  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Injection site reaction  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Infusion related reaction  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Hepatobiliary disorders           
Hepatic failure  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Immune system disorders           
Allergic reaction  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations           
Catheter-related infection  1  1/26 (3.85%)  1 4/39 (10.26%)  5 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Infections and infestations - Other, specify  1  3/26 (11.54%)  3 10/39 (25.64%)  11 6/24 (25.00%)  7 7/34 (20.59%)  7 8/35 (22.86%)  8
Bladder infection  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Lung infection  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Upper respiratory infection  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Peripheral nerve infection  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Sepsis  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 1/34 (2.94%)  1 2/35 (5.71%)  2
Investigations           
Activated partial thromboplastin time prolonged  1  4/26 (15.38%)  4 2/39 (5.13%)  2 1/24 (4.17%)  1 4/34 (11.76%)  4 2/35 (5.71%)  2
Alanine aminotransferase increased  1  1/26 (3.85%)  1 4/39 (10.26%)  5 1/24 (4.17%)  1 0/34 (0.00%)  0 2/35 (5.71%)  2
Blood bilirubin increased  1  2/26 (7.69%)  2 5/39 (12.82%)  5 1/24 (4.17%)  1 3/34 (8.82%)  3 3/35 (8.57%)  3
Creatinine increased  1  4/26 (15.38%)  4 3/39 (7.69%)  3 2/24 (8.33%)  2 3/34 (8.82%)  3 1/35 (2.86%)  1
Electrocardiogram QT corrected interval prolong  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Lymphocyte count decreased  1  24/26 (92.31%)  27 36/39 (92.31%)  40 23/24 (95.83%)  26 34/34 (100.00%)  37 35/35 (100.00%)  36
Neutrophil count decreased  1  24/26 (92.31%)  26 36/39 (92.31%)  41 23/24 (95.83%)  25 33/34 (97.06%)  34 35/35 (100.00%)  35
Platelet count decreased  1  21/26 (80.77%)  22 34/39 (87.18%)  37 23/24 (95.83%)  24 32/34 (94.12%)  32 31/35 (88.57%)  31
Urine output decreased  1  5/26 (19.23%)  5 2/39 (5.13%)  2 3/24 (12.50%)  3 2/34 (5.88%)  2 1/35 (2.86%)  1
White blood cell decreased  1  14/26 (53.85%)  26 36/39 (92.31%)  37 22/24 (91.67%)  22 33/34 (97.06%)  33 35/35 (100.00%)  35
Alkaline phosphatase increased  1  0/26 (0.00%)  0 1/39 (2.56%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Aspartate aminotransferase increased  1  0/26 (0.00%)  0 3/39 (7.69%)  4 1/24 (4.17%)  1 0/34 (0.00%)  0 1/35 (2.86%)  1
Weight gain  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Metabolism and nutrition disorders           
Dehydration  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Hypermagnesemia  1  1/26 (3.85%)  1 2/39 (5.13%)  2 2/24 (8.33%)  2 0/34 (0.00%)  0 0/35 (0.00%)  0
Hyperuricemia  1  4/26 (15.38%)  4 5/39 (12.82%)  5 1/24 (4.17%)  1 0/34 (0.00%)  0 1/35 (2.86%)  1
Hypoalbuminemia  1  14/26 (53.85%)  14 10/39 (25.64%)  11 5/24 (20.83%)  5 7/34 (20.59%)  8 2/35 (5.71%)  2
Hypocalcemia  1  5/26 (19.23%)  7 4/39 (10.26%)  4 4/24 (16.67%)  5 4/34 (11.76%)  5 4/35 (11.43%)  4
Hypoglycemia  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Hyponatremia  1  7/26 (26.92%)  9 4/39 (10.26%)  5 0/24 (0.00%)  0 2/34 (5.88%)  2 2/35 (5.71%)  2
Hypokalemia  1  8/26 (30.77%)  8 3/39 (7.69%)  3 3/24 (12.50%)  3 2/34 (5.88%)  2 2/35 (5.71%)  2
Hypophosphatemia  1  9/26 (34.62%)  9 7/39 (17.95%)  9 7/24 (29.17%)  8 10/34 (29.41%)  10 5/35 (14.29%)  5
Anorexia  1  0/26 (0.00%)  0 1/39 (2.56%)  1 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Acidosis  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Glucose intolerance  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Bone pain  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Myalgia  1  1/26 (3.85%)  1 3/39 (7.69%)  3 4/24 (16.67%)  4 0/34 (0.00%)  0 2/35 (5.71%)  2
Pain in extremity  1  1/26 (3.85%)  1 2/39 (5.13%)  2 1/24 (4.17%)  1 1/34 (2.94%)  2 0/35 (0.00%)  0
Back pain  1  0/26 (0.00%)  0 4/39 (10.26%)  4 0/24 (0.00%)  0 2/34 (5.88%)  2 0/35 (0.00%)  0
Back pain  1  0/26 (0.00%)  0 4/39 (10.26%)  4 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Chest wall pain  1  0/26 (0.00%)  0 2/39 (5.13%)  2 1/24 (4.17%)  1 0/34 (0.00%)  0 1/35 (2.86%)  1
Neck pain  1  0/26 (0.00%)  0 1/39 (2.56%)  1 2/24 (8.33%)  2 1/34 (2.94%)  1 0/35 (0.00%)  0
Muscle weakness left-sided  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumor pain  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Nervous system disorders           
Headache  1  1/26 (3.85%)  1 11/39 (28.21%)  12 4/24 (16.67%)  4 2/34 (5.88%)  3 4/35 (11.43%)  4
peripheral sensory neuropathy  1  1/26 (3.85%)  1 0/39 (0.00%)  0 2/24 (8.33%)  2 0/34 (0.00%)  0 0/35 (0.00%)  0
Ataxia  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Dizziness  1  0/26 (0.00%)  0 4/39 (10.26%)  4 3/24 (12.50%)  3 0/34 (0.00%)  0 1/35 (2.86%)  1
Pyramidal tract syndrome  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Somnolence  1  0/26 (0.00%)  0 0/39 (0.00%)  0 2/24 (8.33%)  2 0/34 (0.00%)  0 0/35 (0.00%)  0
Depressed level of consciousness  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Cognitive disturbance  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 1/34 (2.94%)  1 1/35 (2.86%)  1
Extrapyramidal disorder  1  0/26 (0.00%)  0 0/39 (0.00%)  0 2/24 (8.33%)  2 0/34 (0.00%)  0 0/35 (0.00%)  0
Syncope  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Psychiatric disorders           
Confusion  1  7/26 (26.92%)  7 9/39 (23.08%)  9 6/24 (25.00%)  6 7/34 (20.59%)  7 2/35 (5.71%)  2
Insomnia  1  1/26 (3.85%)  1 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Agitation  1  0/26 (0.00%)  0 3/39 (7.69%)  3 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Psychosis  1  0/26 (0.00%)  0 13/39 (33.33%)  15 8/24 (33.33%)  9 7/34 (20.59%)  7 5/35 (14.29%)  5
Psychiatric disorders - Other, specify  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Depression  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Anxiety  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 1/35 (2.86%)  1
Renal and urinary disorders           
Acute kidney injury  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Hematuria  1  0/26 (0.00%)  0 1/39 (2.56%)  1 2/24 (8.33%)  2 0/34 (0.00%)  0 1/35 (2.86%)  1
Urinary tract obstruction  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Reproductive system and breast disorders           
Irregular menstruation  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Pelvic pain  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  4/26 (15.38%)  4 2/39 (5.13%)  2 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Dyspnea  1  12/26 (46.15%)  12 29/39 (74.36%)  29 11/24 (45.83%)  13 18/34 (52.94%)  18 9/35 (25.71%)  10
Hypoxia  1  5/26 (19.23%)  6 17/39 (43.59%)  17 4/24 (16.67%)  4 9/34 (26.47%)  9 6/35 (17.14%)  6
Bronchospasm  1  0/26 (0.00%)  0 3/39 (7.69%)  3 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Epistaxis  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Hiccups  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Laryngeal edema  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Pharyngolaryngeal pain  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Pleural effusion  1  0/26 (0.00%)  0 4/39 (10.26%)  5 1/24 (4.17%)  1 1/34 (2.94%)  1 1/35 (2.86%)  1
Pneumonitis  1  0/26 (0.00%)  0 1/39 (2.56%)  1 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Voice alteration  1  0/26 (0.00%)  0 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Bronchopulmonary hemorrhage  1  0/26 (0.00%)  0 0/39 (0.00%)  0 1/24 (4.17%)  1 0/34 (0.00%)  0 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders           
Purpura  1  1/26 (3.85%)  1 9/39 (23.08%)  9 4/24 (16.67%)  4 0/34 (0.00%)  0 0/35 (0.00%)  0
Palmer-plantar erythrodyesthesia syndrome  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Pruritus  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 1/34 (2.94%)  1 0/35 (0.00%)  0
Rash maculo-papular  1  0/26 (0.00%)  0 16/39 (41.03%)  17 11/24 (45.83%)  11 6/34 (17.65%)  6 3/35 (8.57%)  3
Skin hypopigmentation  1  0/26 (0.00%)  0 1/39 (2.56%)  1 2/24 (8.33%)  2 1/34 (2.94%)  1 1/35 (2.86%)  1
Skin ulceration  1  0/26 (0.00%)  0 2/39 (5.13%)  2 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders           
Capillary leak syndrome  1  10/26 (38.46%)  10 7/39 (17.95%)  7 2/24 (8.33%)  4 7/34 (20.59%)  7 2/35 (5.71%)  2
Hot flashes  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Hypotension  1  3/26 (11.54%)  4 1/39 (2.56%)  1 0/24 (0.00%)  0 3/34 (8.82%)  3 4/35 (11.43%)  4
Thromboembolic event  1  1/26 (3.85%)  1 0/39 (0.00%)  0 0/24 (0.00%)  0 1/34 (2.94%)  1 1/35 (2.86%)  1
Hypertension  1  0/26 (0.00%)  0 1/39 (2.56%)  1 0/24 (0.00%)  0 0/34 (0.00%)  0 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00513604     History of Changes
Other Study ID Numbers: 070176
07-C-0176
First Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: February 19, 2013
Results First Posted: May 27, 2013
Last Update Posted: June 3, 2013