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Trial record 46 of 49 for:    Peptide Receptor | Neuroendocrine Tumors

Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients

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: NCT00706992
Recruitment Status : Terminated (<11 subjects were enrolled to each Arm)
First Posted : June 30, 2008
Results First Posted : March 19, 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: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Biological: ALVAC-MART-1 vaccine
Biological: MART-1:26-35(27L) peptide vaccine
Biological: Aldesleukin
Biological: autologous anti-MART-1 F5 T-cell receptor gene-engineered peripheral blood lymphocytes
Biological: incomplete Freund's adjuvant
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I - Adj-4 A2 F5 Cells Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide Arm III - Adj-4 A2 F5 Cells + SQ IL-2 Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2 Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2 Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
Hide Arm/Group Description Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL). Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously. Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
Period Title: Overall Study
Started 8 8 9 8 6 5 6
Completed 3 3 3 6 2 3 3
Not Completed 5 5 6 2 4 2 3
Reason Not Completed
Study termination             5             5             6             2             3             2             3
Disease progression before treatment             0             0             0             0             1             0             0
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V Arm VI Arm VII Total
Hide Arm/Group Description Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL). Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously. Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL). Total of all reporting groups
Overall Number of Baseline Participants 8 8 9 8 6 5 6 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
9
 100.0%
8
 100.0%
6
 100.0%
5
 100.0%
6
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
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 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
51.0  (12.9) 47.4  (8.9) 43.1  (11.4) 51.4  (9.7) 49.2  (8.3) 49.0  (11.2) 39.2  (5.7) 47.2  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
Female
4
  50.0%
3
  37.5%
5
  55.6%
1
  12.5%
3
  50.0%
1
  20.0%
3
  50.0%
20
  40.0%
Male
4
  50.0%
5
  62.5%
4
  44.4%
7
  87.5%
3
  50.0%
4
  80.0%
3
  50.0%
30
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
Hispanic or Latino
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Not Hispanic or Latino
8
 100.0%
7
  87.5%
9
 100.0%
8
 100.0%
6
 100.0%
5
 100.0%
6
 100.0%
49
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
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 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
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%
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%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
White
8
 100.0%
7
  87.5%
8
  88.9%
8
 100.0%
6
 100.0%
5
 100.0%
6
 100.0%
48
  96.0%
More than one race
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
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 8 participants 8 participants 9 participants 8 participants 6 participants 5 participants 6 participants 50 participants
8 8 9 8 6 5 6 50
1.Primary Outcome
Title Percentage of Participants With Immunologic Response
Hide Description Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.
Time Frame 9/24/08-10/9/12
Hide Outcome Measure Data
Hide Analysis Population Description
Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.
Arm/Group Title Arm I - 6
Hide Arm/Group Description:
Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Percentage of participants
0
2.Primary Outcome
Title Number of Participants With Adverse Events
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 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - Adj-4 A2 F5 Cells Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide Arm III - Adj-4 A2 F5 Cells + SQ IL-2 Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2 Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2 Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine
Hide Arm/Group Description:
Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
Overall Number of Participants Analyzed 8 8 9 8 6 5 6
Measure Type: Number
Unit of Measure: Participants
8 7 8 8 4 5 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II Arm III Arm IV Arm V Arm VI Arm VII
Hide Arm/Group Description Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously. Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL). Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously. Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
All-Cause Mortality
Arm I Arm II Arm III Arm IV Arm V Arm VI Arm VII
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II Arm III Arm IV Arm V Arm VI Arm VII
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/6 (0.00%)      0/5 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II Arm III Arm IV Arm V Arm VI Arm VII
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      7/8 (87.50%)      8/9 (88.89%)      8/8 (100.00%)      4/6 (66.67%)      5/5 (100.00%)      1/6 (16.67%)    
Blood and lymphatic system disorders               
Hemoglobin  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Lymphopenia  1  0/8 (0.00%)  0 1/8 (12.50%)  1 5/9 (55.56%)  5 7/8 (87.50%)  7 0/6 (0.00%)  0 5/5 (100.00%)  5 0/6 (0.00%)  0
Cardiac disorders               
Hypotension  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 2/5 (40.00%)  2 0/6 (0.00%)  0
Eye disorders               
OCULAR/VISUAL:: Ocular/Visual-Other, left conjunctivitis (inflammation)  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Vision-blurred vision  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 1/8 (12.50%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
OCULAR/VISUAL:: Ocular/Visual-Other (Specify)  1 [1]  0/8 (0.00%)  0 0/8 (0.00%)  0 2/9 (22.22%)  2 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
OCULAR/VISUAL:: Ocular/Visual-Other, vision changes  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Uveitis  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders               
Anorexia  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal - Other, sigmoid diverticulosis (incidental finding on CT scan)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
General disorders               
Pain - Other, body aches  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Rigors/chills  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Pain  1  0/8 (0.00%)  0 1/8 (12.50%)  1 2/9 (22.22%)  2 2/8 (25.00%)  4 0/6 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 2/9 (22.22%)  2 1/8 (12.50%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Pain - Other, body pain  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations               
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutropenia  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders               
Albumin, serum-low (hypoalbuminemia)  1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/9 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  2
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 2/9 (22.22%)  2 4/8 (50.00%)  4 0/6 (0.00%)  0 3/5 (60.00%)  3 0/6 (0.00%)  0
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 2/9 (22.22%)  2 5/8 (62.50%)  5 0/6 (0.00%)  0 3/5 (60.00%)  3 0/6 (0.00%)  0
Alkaline phosphatase  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Creatinine  1  0/8 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Nervous system disorders               
Psychosis (hallucinations/delusions)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Dyspnea (shortness of breath)  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders               
Rash/desquamation  1  7/8 (87.50%)  7 1/8 (12.50%)  1 7/9 (77.78%)  7 5/8 (62.50%)  5 4/6 (66.67%)  4 3/5 (60.00%)  3 0/6 (0.00%)  0
Urticaria (hives, welts, wheals)  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Hypopigmentation  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/9 (11.11%)  1 1/8 (12.50%)  1 0/6 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0
Injection site reaction/extravasation changes  1  0/8 (0.00%)  0 6/8 (75.00%)  6 0/9 (0.00%)  0 1/8 (12.50%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Decreased vision; Blurry vision due to retinal edema
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
Layout table for additonal information
Responsible Party: Steven Rosenberg, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00706992     History of Changes
Other Study ID Numbers: 080162
08-C-0162
First Submitted: June 27, 2008
First Posted: June 30, 2008
Results First Submitted: December 18, 2012
Results First Posted: March 19, 2013
Last Update Posted: October 28, 2015