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Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer

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: NCT01560923
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metastatic Prostate Cancer
Interventions Biological: Indoximod
Biological: Sipuleucel-T
Other: Placebo
Enrollment 47
Recruitment Details  
Pre-assignment Details One patient withdrew or refused to participate after receiving protocol therapy
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Period Title: Overall Study
Started 24 22
Completed 24 22
Not Completed 0 0
Arm/Group Title Control (Placebo) Arm Treatment Total
Hide Arm/Group Description

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  25.0%
9
  40.9%
15
  32.6%
>=65 years
18
  75.0%
13
  59.1%
31
  67.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
22
 100.0%
46
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Hispanic or Latino
1
   4.2%
0
   0.0%
1
   2.2%
Not Hispanic or Latino
22
  91.7%
22
 100.0%
44
  95.7%
Unknown or Not Reported
1
   4.2%
0
   0.0%
1
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
American Indian or Alaska Native
1
   4.2%
2
   9.1%
3
   6.5%
Asian
0
   0.0%
1
   4.5%
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.5%
1
   2.2%
White
23
  95.8%
16
  72.7%
39
  84.8%
More than one race
0
   0.0%
1
   4.5%
1
   2.2%
Unknown or Not Reported
0
   0.0%
1
   4.5%
1
   2.2%
1.Primary Outcome
Title Immune Response to Sipuleucel-T
Hide Description

Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.

The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm.

Time Frame 14 Weeks from First Leukapheresis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Spots per ml
29.6
(4.86 to 180.37)
25.45
(2.92 to 222.12)
2.Secondary Outcome
Title Number of Participants With Progression Free Survival at 6 Months
Hide Description

Progression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression.

Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
6
  25.0%
11
  50.0%
3.Secondary Outcome
Title Objective Response Rate
Hide Description

rate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
Partial response (PR)
1
   4.2%
0
   0.0%
Not Evaluable
0
   0.0%
2
   9.1%
Stable Disease (SD)
5
  20.8%
11
  50.0%
Baseline
3
  12.5%
1
   4.5%
Non-CR/Non-PD
1
   4.2%
1
   4.5%
Progressive Disease (PD)
12
  50.0%
7
  31.8%
Not Assessed
2
   8.3%
0
   0.0%
4.Secondary Outcome
Title Overall Survival
Hide Description To evaluate 2 year overall survival
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
18
  75.0%
17
  77.3%
5.Secondary Outcome
Title Quality of Life Scale Results
Hide Description measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead'
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Performance Status Score 0 - Normal activity, Fully active
19
  79.2%
15
  68.2%
1- Symptoms but ambulatory
5
  20.8%
7
  31.8%
No Data
0
   0.0%
0
   0.0%
Post Treatment performance Status Score 0 - Normal activity, Fully active
7
  29.2%
9
  40.9%
1- Symptoms but ambulatory
10
  41.7%
3
  13.6%
No Data
7
  29.2%
10
  45.5%
6.Secondary Outcome
Title Ratio of Antibodies to PA2024
Hide Description

Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.

The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024.

Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm.

Time Frame 14 Weeks from First Leukapheresis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sipuleucel-T + Placebo Sipuleucel-T + Oral Indoximod
Hide Arm/Group Description:

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Overall Number of Participants Analyzed 24 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
PA2024 IGG ratio (wk14/baseline)
13.05
(5.05 to 33.72)
9.19
(3.04 to 27.8)
PA2024 IGGIGM ratio (wk14/baseline)
104.39
(33.88 to 321.66)
111.43
(35.49 to 349.89)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sipuleucel-T + Indoximod Sipuleucel-T + Placebo
Hide Arm/Group Description

Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.

Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo is identical-looking to Indoximod and provided in the same manner.

Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).

Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.

All-Cause Mortality
Sipuleucel-T + Indoximod Sipuleucel-T + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/22 (22.73%)      6/24 (25.00%)    
Hide Serious Adverse Events
Sipuleucel-T + Indoximod Sipuleucel-T + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      1/24 (4.17%)    
Infections and infestations     
Sepsis   0/22 (0.00%)  0 1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders     
Flank pain   1/22 (4.55%)  1 0/24 (0.00%)  0
Renal and urinary disorders     
Urinary tract obstruction   1/22 (4.55%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sipuleucel-T + Indoximod Sipuleucel-T + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/22 (90.91%)      21/24 (87.50%)    
Blood and lymphatic system disorders     
Positive ANA panel 1:320   1/22 (4.55%)  1 0/24 (0.00%)  0
Anemia   1/22 (4.55%)  1 1/24 (4.17%)  1
Lymph node pain (bilateral inguinal)   1/22 (4.55%)  1 0/24 (0.00%)  0
White blood cell count decreased   0/22 (0.00%)  0 1/24 (4.17%)  1
Cardiac disorders     
Atrial flutter   1/22 (4.55%)  1 0/24 (0.00%)  0
Ear and labyrinth disorders     
Middle ear effusion   1/22 (4.55%)  1 0/24 (0.00%)  0
Ear pain   0/22 (0.00%)  0 1/24 (4.17%)  1
Eye disorders     
Blurred vision   0/22 (0.00%)  0 2/24 (8.33%)  2
Watering eyes   0/22 (0.00%)  0 1/24 (4.17%)  1
Gastrointestinal disorders     
Abdominal distension   1/22 (4.55%)  1 1/24 (4.17%)  1
Abdominal pain   4/22 (18.18%)  5 0/24 (0.00%)  0
Bloating   2/22 (9.09%)  2 0/24 (0.00%)  0
Constipation   4/22 (18.18%)  6 4/24 (16.67%)  5
Diarrhea   2/22 (9.09%)  3 6/24 (25.00%)  10
Dyspepsia   1/22 (4.55%)  1 2/24 (8.33%)  2
Increased appetite   0/22 (0.00%)  0 1/24 (4.17%)  1
Nausea   3/22 (13.64%)  4 4/24 (16.67%)  5
Mouth sores   0/22 (0.00%)  0 1/24 (4.17%)  1
Vomiting   2/22 (9.09%)  3 1/24 (4.17%)  1
Flatulence   1/22 (4.55%)  1 0/24 (0.00%)  0
Rectal Mucus   1/22 (4.55%)  1 0/24 (0.00%)  0
Gastrointestinal pain   1/22 (4.55%)  2 1/24 (4.17%)  1
Teeth discomfort   1/22 (4.55%)  1 0/24 (0.00%)  0
GERD   1/22 (4.55%)  3 2/24 (8.33%)  2
General disorders     
Chills   1/22 (4.55%)  1 3/24 (12.50%)  4
TMJ pain   0/22 (0.00%)  0 1/24 (4.17%)  1
Fatique   9/22 (40.91%)  11 7/24 (29.17%)  10
Fever   3/22 (13.64%)  3 2/24 (8.33%)  2
Flu like symptoms   1/22 (4.55%)  1 3/24 (12.50%)  3
Other general disorders -Reflux   0/22 (0.00%)  0 2/24 (8.33%)  3
Pain   1/22 (4.55%)  1 5/24 (20.83%)  13
Edema   2/22 (9.09%)  2 2/24 (8.33%)  2
Chest pressure   0/22 (0.00%)  0 1/24 (4.17%)  1
Other; Tongue Swelling   1/22 (4.55%)  1 0/24 (0.00%)  0
Other; Spinal tenderness   1/22 (4.55%)  1 0/24 (0.00%)  0
Infusion related reaction   1/22 (4.55%)  2 1/24 (4.17%)  1
Other; Fatigue   1/22 (4.55%)  1 0/24 (0.00%)  0
Infections and infestations     
Toe fungal infection   1/22 (4.55%)  2 0/24 (0.00%)  0
Toxoplasma exposure   0/22 (0.00%)  0 1/24 (4.17%)  1
Sepsis   0/22 (0.00%)  0 1/24 (4.17%)  1
sinusitis   0/22 (0.00%)  0 1/24 (4.17%)  1
Skin infection   1/22 (4.55%)  1 1/24 (4.17%)  1
Upper respiratory infection   2/22 (9.09%)  2 1/24 (4.17%)  1
right leg infection   0/22 (0.00%)  0 1/24 (4.17%)  1
Bronchitis   0/22 (0.00%)  0 1/24 (4.17%)  1
Rhinitis infective   0/22 (0.00%)  0 1/24 (4.17%)  2
Papular rash to nose and left neck   1/22 (4.55%)  1 0/24 (0.00%)  0
Injury, poisoning and procedural complications     
Left fibula fracture   0/22 (0.00%)  0 1/24 (4.17%)  2
Issues with return IV   1/22 (4.55%)  1 0/24 (0.00%)  0
Spinal fracture   1/22 (4.55%)  1 0/24 (0.00%)  0
Bleeding to cather   1/22 (4.55%)  1 0/24 (0.00%)  0
Investigations     
Alanine aminotransferase increased   0/22 (0.00%)  0 1/24 (4.17%)  2
Elevated alkaline phosphatase   1/22 (4.55%)  3 1/24 (4.17%)  1
Aspartate aminotransferase increased   0/22 (0.00%)  0 1/24 (4.17%)  2
Creatinine increased   1/22 (4.55%)  1 0/24 (0.00%)  0
Anemia   1/22 (4.55%)  1 0/24 (0.00%)  0
Weight gain   0/22 (0.00%)  0 2/24 (8.33%)  2
Metabolism and nutrition disorders     
Anorexia   0/22 (0.00%)  0 1/24 (4.17%)  1
Hyperglycemia, intermittent   0/22 (0.00%)  0 1/24 (4.17%)  2
Hypermagnesemia   0/22 (0.00%)  0 1/24 (4.17%)  1
Hypokalemia   1/22 (4.55%)  3 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia   3/22 (13.64%)  3 4/24 (16.67%)  6
Back pain   6/22 (27.27%)  8 7/24 (29.17%)  7
Bone pain   3/22 (13.64%)  3 2/24 (8.33%)  3
Chest wall pain   1/22 (4.55%)  2 1/24 (4.17%)  1
flank pain   0/22 (0.00%)  0 1/24 (4.17%)  1
Neck pain   1/22 (4.55%)  1 1/24 (4.17%)  1
Pain in extremity   2/22 (9.09%)  3 0/24 (0.00%)  0
Buttock pain   1/22 (4.55%)  1 0/24 (0.00%)  0
Weakness   1/22 (4.55%)  2 2/24 (8.33%)  2
Muscle weakness upper limb   0/22 (0.00%)  0 1/24 (4.17%)  1
Other; Stiffness   1/22 (4.55%)  2 0/24 (0.00%)  0
Other; Muscle cramp   1/22 (4.55%)  1 0/24 (0.00%)  0
Other; Shoulder pain   1/22 (4.55%)  1 0/24 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lipoma   0/22 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders     
Dizziness   3/22 (13.64%)  3 0/24 (0.00%)  0
Headache   4/22 (18.18%)  4 4/24 (16.67%)  4
Memory loss   2/22 (9.09%)  2 0/24 (0.00%)  0
Nueropathy   0/22 (0.00%)  0 2/24 (8.33%)  2
Paresthesia   1/22 (4.55%)  1 2/24 (8.33%)  2
Peripheral motor neuropathy   0/22 (0.00%)  0 1/24 (4.17%)  1
Psychiatric disorders     
Anxiety   2/22 (9.09%)  2 1/24 (4.17%)  2
Insomnia   1/22 (4.55%)  1 1/24 (4.17%)  1
Depression   0/22 (0.00%)  0 1/24 (4.17%)  1
Renal and urinary disorders     
Hematuria   0/22 (0.00%)  0 1/24 (4.17%)  1
Urinary hesitancy   1/22 (4.55%)  1 0/24 (0.00%)  0
Bladder incontinence   0/22 (0.00%)  0 2/24 (8.33%)  3
Reproductive system and breast disorders     
Pelvic pain   2/22 (9.09%)  2 1/24 (4.17%)  1
Erectile Dysfunction   2/22 (9.09%)  2 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough   1/22 (4.55%)  1 3/24 (12.50%)  3
Dyspnea   1/22 (4.55%)  1 0/24 (0.00%)  0
Congestion   2/22 (9.09%)  2 0/24 (0.00%)  0
Wheezing   1/22 (4.55%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia   2/22 (9.09%)  2 0/24 (0.00%)  0
Hyperhidrosis   1/22 (4.55%)  1 0/24 (0.00%)  0
Photosensitivity   1/22 (4.55%)  1 0/24 (0.00%)  0
Pruritus   1/22 (4.55%)  2 1/24 (4.17%)  1
Rash   4/22 (18.18%)  5 1/24 (4.17%)  1
Urticaria   1/22 (4.55%)  2 0/24 (0.00%)  0
Other; Slight rash   2/22 (9.09%)  4 0/24 (0.00%)  0
Other; Dermatitis Scrotum   0/22 (0.00%)  0 1/24 (4.17%)  1
Other; Slight thickening of the skin   1/22 (4.55%)  1 0/24 (0.00%)  0
ecchymois bilateral arms from leukapheresis access site   0/22 (0.00%)  0 1/24 (4.17%)  2
Vascular disorders     
Flushing   1/22 (4.55%)  1 0/24 (0.00%)  0
Hematuria   1/22 (4.55%)  1 0/24 (0.00%)  0
Hot flashes   3/22 (13.64%)  3 5/24 (20.83%)  5
Hypertension   3/22 (13.64%)  3 1/24 (4.17%)  6
Thromoembolic event   1/22 (4.55%)  2 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Gautam Jha
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-624-5373
EMail: jhaxx014@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01560923    
Other Study ID Numbers: 2011LS109
First Submitted: March 20, 2012
First Posted: March 22, 2012
Results First Submitted: March 6, 2020
Results First Posted: April 3, 2020
Last Update Posted: April 3, 2020