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MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01273181
Recruitment Status : Terminated
First Posted : January 10, 2011
Results First Posted : March 27, 2013
Last Update Posted : October 28, 2015
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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Cancer
Metastatic Renal Cancer
Metastatic Melanoma
Interventions Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes
Drug: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine
Enrollment 9
Recruitment Details  
Pre-assignment Details Ph I:study will begin by evaluating the safety of 2 ranges of cells,5x10^9-3x10^10, & >3x10^10-1x10^11 in a standard ph I dose escalation using a 3+3 design. Ph II:pts will be entered into 2 cohorts based on histology:cohort 1 will include pts with metastatic melanoma or RCC; cohort 2 will include pts with other types of metastatic cancer.
Arm/Group Title Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Hide Arm/Group Description

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
Period Title: Phase I, Dose 1
Started 3 0 0 0
Completed 2 0 0 0
Not Completed 1 0 0 0
Reason Not Completed
Study termination             1             0             0             0
Period Title: Phase I, Dose 2
Started 0 3 0 0
Completed 0 2 0 0
Not Completed 0 1 0 0
Reason Not Completed
Death during treatment             0             1             0             0
Period Title: Phase 2, Dose 1
Started 0 0 2 0
Completed 0 0 1 0
Not Completed 0 0 1 0
Reason Not Completed
Study termination             0             0             1             0
Period Title: Phase 2, Dose 2
Started 0 0 0 1
Completed 0 0 0 0
Not Completed 0 0 0 1
Reason Not Completed
Death during treatment             0             0             0             1
Arm/Group Title Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer Total
Hide Arm/Group Description

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Total of all reporting groups
Overall Number of Baseline Participants 3 3 2 1 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 2 participants 1 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
2
 100.0%
0
   0.0%
8
  88.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
  11.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 2 participants 1 participants 9 participants
51.0  (11.4) 39.7  (16.9) 62.0  (0.0) 71.0 51.9  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 2 participants 1 participants 9 participants
Female
2
  66.7%
1
  33.3%
1
  50.0%
1
 100.0%
5
  55.6%
Male
1
  33.3%
2
  66.7%
1
  50.0%
0
   0.0%
4
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 2 participants 1 participants 9 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
2
 100.0%
1
 100.0%
9
 100.0%
Unknown or Not Reported
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 3 participants 3 participants 2 participants 1 participants 9 participants
American Indian or Alaska Native
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%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
00
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
2
 100.0%
1
 100.0%
9
 100.0%
More than one race
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 2 participants 1 participants 9 participants
3 3 2 1 9
1.Primary Outcome
Title Toxicity Profile
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 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Hide Arm/Group Description:

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Overall Number of Participants Analyzed 3 3 2 1
Measure Type: Number
Unit of Measure: Participants
3 3 2 1
2.Primary Outcome
Title Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer
Hide Description Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-MAGE TCR PBL 5x10e9 +HD IL-2 Anti-MAGE TCR PBL 5x10e10 +HD IL-2 Anti-MAGE TCR PBL+HD IL-2, Mel, RCC Anti-MAGE TCR PBL +HD IL-2, Other
Hide Arm/Group Description:

anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Overall Number of Participants Analyzed 3 3 2 1
Measure Type: Number
Unit of Measure: Participants
Complete Response 1 0 0 0
Partial Response 1 2 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Hide Arm/Group Description

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer

Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)

Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses

PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :

Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

All-Cause Mortality
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/3 (33.33%)      2/2 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders         
Hemoglobin  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders         
Left ventricular diastolic dysfunction  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Hypotension  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Gastrointestinal disorders         
Anorexia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Nausea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
General disorders         
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Death not associated with CTCAE term  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 1/1 (100.00%)  1
Metabolism and nutrition disorders         
ALT/SGPT (serum glutamic pyruvic transaminase)  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
AST/SGOT (serum glutamic oxaloacetic transaminase)  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Amylase  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders         
Somnolence/depressed level of consciousness  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 1/1 (100.00%)  1
Seizure  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/2 (50.00%)  1 0/1 (0.00%)  0
Speech impairment (e.g. dysphasia or aphasia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0
Renal and urinary disorders         
Renal failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnea (shortness of breath)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Hypoxia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9 Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10 Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      2/2 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders         
Hemoglobin  1  1/3 (33.33%)  1 2/3 (66.67%)  2 2/2 (100.00%)  2 1/1 (100.00%)  1
Leukocytes (total WBC)  1  3/3 (100.00%)  3 3/3 (100.00%)  3 2/2 (100.00%)  2 1/1 (100.00%)  1
Lymphopenia  1  3/3 (100.00%)  3 3/3 (100.00%)  3 2/2 (100.00%)  2 1/1 (100.00%)  1
Neutrophils/granulocytes (ANC/AGC)  1  3/3 (100.00%)  3 3/3 (100.00%)  3 2/2 (100.00%)  2 1/1 (100.00%)  1
Platelets  1  3/3 (100.00%)  3 3/3 (100.00%)  3 2/2 (100.00%)  2 1/1 (100.00%)  1
PTT (partial thromboplastin time)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Cardiac disorders         
Supraventricular & nodal arrhythmia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Hypotension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Gastrointestinal disorders         
Diarrhea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
General disorders         
Pain  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Infections and infestations         
Febrile neutropenia  1 [1]  3/3 (100.00%)  3 3/3 (100.00%)  3 1/2 (50.00%)  1 0/1 (0.00%)  0
Infection  1  0/3 (0.00%)  0 2/3 (66.67%)  2 2/2 (100.00%)  2 1/1 (100.00%)  1
Metabolism and nutrition disorders         
Albumin, serum-low (hypoalbuminemia)  1  1/3 (33.33%)  1 2/3 (66.67%)  2 1/2 (50.00%)  1 1/1 (100.00%)  1
Bilirubin (hyperbilirubinemia)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Lipase  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  3/3 (100.00%)  3 2/3 (66.67%)  2 1/2 (50.00%)  1 1/1 (100.00%)  1
Potassium, serum-low (hypokalemia)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Uric acid, serum-high (hyperuricemia)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/2 (50.00%)  1 0/1 (0.00%)  0
Creatinine  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 1/1 (100.00%)  1
Magnesium, serum-high (hypermagnesemia)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Glucose, serum-high (hyperglycemia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Sodium, serum-low (hyponatremia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Nervous system disorders         
Confusion  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
Psychosis (hallucinations/delusions)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/1 (0.00%)  0
CNS cerebrovascular ischemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Hypoxia  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/1 (0.00%)  0
Dyspnea (shortness of breath)  1  0/3 (0.00%)  0 2/3 (66.67%)  2 1/2 (50.00%)  1 0/1 (0.00%)  0
Vascular disorders         
Acute vascular leak syndrome  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Rosenberg
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
EMail: sar@mail.nih.gov
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Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01273181    
Other Study ID Numbers: 110062
11-C-0062
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: February 14, 2013
Results First Posted: March 27, 2013
Last Update Posted: October 28, 2015