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SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

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: NCT01362790
Recruitment Status : Completed
First Posted : May 30, 2011
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Raffit Hassan, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mesothelioma
Adenocarcinoma of Lung
Pancreatic Neoplasms
Interventions Drug: Pentostatin
Drug: Cyclophosphamide
Biological: SS1(dsFv)PE38 - lot 073I0809
Biological: SS1(dsFv)PE38 - lot FIL129J01
Enrollment 55
Recruitment Details  
Pre-assignment Details 55 participants were enrolled. No data was collected for 10/55 participants who were screened for neutralizing antibodies and were positive, thus not enrolled into a Group /Arm, nor treated. 45/55 participants were treated on this study.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Period Title: Pilot Phase & Phase 2
Started 11 8 7 15 0 4 0
Completed 1 0 2 1 0 0 0
Not Completed 10 8 5 14 0 4 0
Reason Not Completed
Changed treatment, too early to assess             1             0             0             0             0             0             0
Adverse Event             0             1             0             1             0             2             0
Physician Decision             0             0             0             1             0             0             0
Developed antibodies             7             2             3             8             0             0             0
Refused further treatment             0             1             0             0             0             0             0
Progressive disease             1             2             2             3             0             2             0
Treatment delay >3 weeks             1             0             0             0             0             0             0
Complicating disease/intercurr. illness             0             2             0             0             0             0             0
Death on study             0             0             0             1             0             0             0
Period Title: Dose De-escalation of Regimen A
Started 0 0 0 0 8 0 0
Completed 0 0 0 0 2 0 0
Not Completed 0 0 0 0 6 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0
Deveoped antibodies             0             0             0             0             3             0             0
Progressive disease             0             0             0             0             2             0             0
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A Total
Hide Arm/Group Description

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Total of all reporting groups
Overall Number of Baseline Participants 11 8 7 15 4 0 45
Hide Baseline Analysis Population Description
No pts were enrolled in Grp7.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
9
  81.8%
7
  87.5%
6
  85.7%
7
  46.7%
4
 100.0%
0
33
  73.3%
>=65 years
2
  18.2%
1
  12.5%
1
  14.3%
8
  53.3%
0
   0.0%
0
12
  26.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
55.27  (7.68) 60.55  (16.41) 49.91  (16.32) 64.21  (7.65) 52.53  (6.77) 56.49  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
Female
4
  36.4%
2
  25.0%
2
  28.6%
5
  33.3%
1
  25.0%
14
  31.1%
Male
7
  63.6%
6
  75.0%
5
  71.4%
10
  66.7%
3
  75.0%
31
  68.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
1
   2.2%
Not Hispanic or Latino
11
 100.0%
8
 100.0%
7
 100.0%
14
  93.3%
4
 100.0%
44
  97.8%
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 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 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
1
   9.1%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
2
   4.4%
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%
1
  14.3%
0
   0.0%
0
   0.0%
1
   2.2%
White
10
  90.9%
8
 100.0%
6
  85.7%
14
  93.3%
4
 100.0%
42
  93.3%
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: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
11
 100.0%
8
 100.0%
7
 100.0%
15
 100.0%
4
 100.0%
45
 100.0%
Count of Participants with a Peritoneum and Pleural Tumor Site   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 8 participants 7 participants 15 participants 4 participants 0 participants 45 participants
Peritoneum
2
  18.2%
1
  12.5%
7
 100.0%
0
   0.0%
0
   0.0%
10
  22.2%
Pleural
9
  81.8%
7
  87.5%
0
   0.0%
15
 100.0%
0
   0.0%
31
  68.9%
Pancreatic
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
 100.0%
4
   8.9%
[1]
Measure Description: The peritoneum is the membrane lining the abdomen. Pleural refers to the fluid filled space between each lung.
1.Primary Outcome
Title Response Assessment
Hide Description Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete 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. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame 52 months and 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
2
  18.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease
5
  45.5%
6
  75.0%
6
  85.7%
6
  40.0%
1
  25.0%
Progressive Disease
3
  27.3%
1
  12.5%
1
  14.3%
3
  20.0%
2
  50.0%
2.Primary Outcome
Title Count of Participants With SS1P Antibody Formation
Hide Description Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P.
Time Frame On last day of last dosing cycle, end of cycle 1 (day 30)
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
6
  54.5%
2
  25.0%
3
  42.9%
7
  46.7%
0
   0.0%
0
3.Primary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 64 months and 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
8
 100.0%
7
 100.0%
15
 100.0%
4
 100.0%
0
4.Primary Outcome
Title Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01
Hide Description Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.
Time Frame Days 1, 3, and 5 of a 21 day cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Meso., Peritoneal, Pleural & Pancreatic Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan

Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: mcg/kg/dose
25
5.Secondary Outcome
Title Overall Survival
Hide Description The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Median (95% Confidence Interval)
Unit of Measure: Months
8.9
(5.4 to 32.2)
11.2
(1.0 to 13.0)
29.3
(3.4 to 29.3)
4.2
(2.0 to 7.9)
9.3
(1.2 to 15.1)
6.Secondary Outcome
Title Progression-free Survival
Hide Description Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Meothelioma Pilot Phase Phase Regimen A Meothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Median (95% Confidence Interval)
Unit of Measure: Months
11.8
(1.6 to 13.6)
8.8
(0.6 to 13.0)
8.9 [1] 
(1.8 to NA)
3.9
(1.6 to 6.4)
4.4
(0.9 to 7.4)
[1]
Upper bound confidence interval is undefined because there are too few subjects and progressions after the median time to estimate the confidence bound; it cannot be calculated.
7.Secondary Outcome
Title Duration of Response
Hide Description DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study).
Time Frame up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here.
Arm/Group Title Mesothelioma Pilot Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles

Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Months
16.3
(10.6 to 26.2)
8.Other Pre-specified Outcome
Title Count of Participants SS1P Cycles Received Following Onstudy
Hide Description Here are the number of participants who had SS1P cycles during cycle 1-6.
Time Frame Cycles 1-6, up to 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Hide Arm/Group Description:

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Overall Number of Participants Analyzed 11 8 7 15 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
SS1P 1 Cycle
1
   9.1%
3
  37.5%
0
   0.0%
5
  33.3%
2
  50.0%
0
SS1P 2 Cycles
8
  72.7%
0
   0.0%
4
  57.1%
8
  53.3%
1
  25.0%
0
SS1P 3 Cycles
0
   0.0%
3
  37.5%
0
   0.0%
1
   6.7%
1
  25.0%
0
SS1P 4 Cycles
1
   9.1%
1
  12.5%
3
  42.9%
0
   0.0%
0
   0.0%
0
SS1P 5 Cycles
0
   0.0%
1
  12.5%
0
   0.0%
1
   6.7%
0
   0.0%
0
SS1P 6 Cycles
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
Time Frame Date treatment consent signed to date off study, approximately 64 months and 26 days.
Adverse Event Reporting Description No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.
 
Arm/Group Title Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
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Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle

Other Names:

• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles

During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle

Other Names:

• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle

Other Names:

• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.

All-Cause Mortality
Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/11 (45.45%)      8/8 (100.00%)      3/7 (42.86%)      9/15 (60.00%)      1/8 (12.50%)      1/4 (25.00%)      0/0    
Hide Serious Adverse Events
Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
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   6/11 (54.55%)      8/8 (100.00%)      3/7 (42.86%)      9/15 (60.00%)      1/8 (12.50%)      1/4 (25.00%)      0/0    
Cardiac disorders               
Atrial fibrillation  1  1/11 (9.09%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
General disorders               
Death NOS  1  5/11 (45.45%)  5 5/8 (62.50%)  5 2/7 (28.57%)  2 4/15 (26.67%)  4 0/8 (0.00%)  0 1/4 (25.00%)  1 0/0  0
Fever  1  1/11 (9.09%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Infections and infestations               
Lung infection  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [1]  0/11 (0.00%)  0 3/8 (37.50%)  3 1/7 (14.29%)  1 4/15 (26.67%)  4 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Renal and urinary disorders               
Acute kidney injury  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders               
Respiratory failure  1  1/11 (9.09%)  1 1/8 (12.50%)  2 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hypoxia  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Respiratory failure  1 [1]  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Death
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mesothelioma Pilot Phase Regimen A Mesothelioma Pilot Phase Regimen B Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase Phase 2 Pleural Mesothelioma Pilot Expansion Phase Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
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   11/11 (100.00%)      8/8 (100.00%)      7/7 (100.00%)      15/15 (100.00%)      8/8 (100.00%)      4/4 (100.00%)      0/0    
Blood and lymphatic system disorders               
Anemia  1  8/11 (72.73%)  31 7/8 (87.50%)  44 4/7 (57.14%)  28 11/15 (73.33%)  39 8/8 (100.00%)  35 4/4 (100.00%)  12 0/0  0
Cardiac disorders               
Asystole  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Atrial fibrillation  1  0/11 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0 2/15 (13.33%)  3 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Atrial flutter  1  2/11 (18.18%)  3 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Cardiac disorders - Other, (coronary artery disease)  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Myocardial infarction  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Sinus bradycardia  1  2/11 (18.18%)  2 0/8 (0.00%)  0 4/7 (57.14%)  5 0/15 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Sinus tachycardia  1  1/11 (9.09%)  1 3/8 (37.50%)  3 2/7 (28.57%)  3 5/15 (33.33%)  10 3/8 (37.50%)  4 0/4 (0.00%)  0 0/0  0
Supraventricular tachycardia  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 3/15 (20.00%)  6 1/8 (12.50%)  2 0/4 (0.00%)  0 0/0  0
Ventricular arrhythmia  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Ear and labyrinth disorders               
Ear pain  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Endocrine disorders               
Hypothyroidism  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Eye disorders               
Blurred vision  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Conjunctivitis  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Corneal ulcer  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Flashing lights  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Photophobia  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Gastrointestinal disorders               
Abdominal distension  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Abdominal pain  1  1/11 (9.09%)  1 2/8 (25.00%)  4 2/7 (28.57%)  6 2/15 (13.33%)  2 2/8 (25.00%)  4 1/4 (25.00%)  1 0/0  0
Anal pain  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Bloating  1  2/11 (18.18%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Constipation  1  8/11 (72.73%)  12 2/8 (25.00%)  3 4/7 (57.14%)  7 6/15 (40.00%)  10 7/8 (87.50%)  9 4/4 (100.00%)  4 0/0  0
Dehydration  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Dry mouth  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Diarrhea  1  1/11 (9.09%)  1 5/8 (62.50%)  5 4/7 (57.14%)  8 3/15 (20.00%)  5 5/8 (62.50%)  9 1/4 (25.00%)  1 0/0  0
Dyspepsia  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Dysphagia  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Flatulence  1  0/11 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Gastroesophageal reflux disease  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Mucositis oral  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Nausea  1  8/11 (72.73%)  9 5/8 (62.50%)  7 5/7 (71.43%)  12 13/15 (86.67%)  28 7/8 (87.50%)  10 2/4 (50.00%)  2 0/0  0
Small intestinal obstruction  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Toothache  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Vomiting  1  3/11 (27.27%)  4 3/8 (37.50%)  6 4/7 (57.14%)  8 6/15 (40.00%)  16 3/8 (37.50%)  4 1/4 (25.00%)  1 0/0  0
General disorders               
Chills  1  1/11 (9.09%)  1 4/8 (50.00%)  5 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Edema face  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Edema limbs  1  6/11 (54.55%)  10 5/8 (62.50%)  9 3/7 (42.86%)  6 11/15 (73.33%)  29 5/8 (62.50%)  10 2/4 (50.00%)  2 0/0  0
Fatigue  1  7/11 (63.64%)  11 4/8 (50.00%)  11 4/7 (57.14%)  8 9/15 (60.00%)  11 7/8 (87.50%)  11 4/4 (100.00%)  5 0/0  0
Fever  1  1/11 (9.09%)  3 4/8 (50.00%)  15 1/7 (14.29%)  1 8/15 (53.33%)  10 4/8 (50.00%)  8 2/4 (50.00%)  6 0/0  0
Pain  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2 4/15 (26.67%)  7 2/8 (25.00%)  2 1/4 (25.00%)  1 0/0  0
Infections and infestations               
Infections and infestations - Other, (folliculitis on abdomen and back)  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Skin infection  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Upper respiratory infection  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Urinary tract infection  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 2/15 (13.33%)  3 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Infections and infestations - Other, (tinea corporis on nape of neck)  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Injury, poisoning and procedural complications               
Aspartate aminotransferase increased  1  7/11 (63.64%)  20 4/8 (50.00%)  17 3/7 (42.86%)  12 7/15 (46.67%)  19 6/8 (75.00%)  16 4/4 (100.00%)  9 0/0  0
Investigations               
Activated partial thromboplastin time prolonged  1  2/11 (18.18%)  2 5/8 (62.50%)  10 1/7 (14.29%)  2 7/15 (46.67%)  10 3/8 (37.50%)  6 2/4 (50.00%)  5 0/0  0
Alanine aminotransferase increased  1  6/11 (54.55%)  17 4/8 (50.00%)  15 2/7 (28.57%)  2 7/15 (46.67%)  19 5/8 (62.50%)  10 4/4 (100.00%)  7 0/0  0
Alkaline phosphatase increased  1  2/11 (18.18%)  4 3/8 (37.50%)  13 3/7 (42.86%)  10 3/15 (20.00%)  5 3/8 (37.50%)  11 2/4 (50.00%)  5 0/0  0
Blood bilirubin increased  1  2/11 (18.18%)  4 2/8 (25.00%)  2 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Creatinine increased  1  3/11 (27.27%)  7 3/8 (37.50%)  14 2/7 (28.57%)  4 7/15 (46.67%)  12 4/8 (50.00%)  8 2/4 (50.00%)  5 0/0  0
Ejection fraction decreased  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Lymphocyte count decreased  1  11/11 (100.00%)  121 8/8 (100.00%)  86 7/7 (100.00%)  83 15/15 (100.00%)  140 8/8 (100.00%)  84 4/4 (100.00%)  22 0/0  0
Neutrophil count decreased  1  2/11 (18.18%)  4 5/8 (62.50%)  16 1/7 (14.29%)  3 3/15 (20.00%)  9 3/8 (37.50%)  13 2/4 (50.00%)  10 0/0  0
Platelet count decreased  1  3/11 (27.27%)  11 7/8 (87.50%)  29 2/7 (28.57%)  4 4/15 (26.67%)  6 3/8 (37.50%)  7 2/4 (50.00%)  4 0/0  0
Weight gain  1  4/11 (36.36%)  6 3/8 (37.50%)  4 2/7 (28.57%)  4 8/15 (53.33%)  25 2/8 (25.00%)  3 0/4 (0.00%)  0 0/0  0
Weight loss  1  0/11 (0.00%)  0 1/8 (12.50%)  4 2/7 (28.57%)  4 2/15 (13.33%)  7 2/8 (25.00%)  4 1/4 (25.00%)  1 0/0  0
White blood cell decreased  1  8/11 (72.73%)  33 7/8 (87.50%)  70 5/7 (71.43%)  25 11/15 (73.33%)  55 7/8 (87.50%)  36 3/4 (75.00%)  19 0/0  0
Lipase increased  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Metabolism and nutrition disorders               
Anorexia  1  6/11 (54.55%)  7 3/8 (37.50%)  3 3/7 (42.86%)  5 3/15 (20.00%)  3 2/8 (25.00%)  4 0/4 (0.00%)  0 0/0  0
Hypercalcemia  1  0/11 (0.00%)  0 2/8 (25.00%)  6 2/7 (28.57%)  8 4/15 (26.67%)  7 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hyperglycemia  1  10/11 (90.91%)  35 6/8 (75.00%)  28 5/7 (71.43%)  12 15/15 (100.00%)  71 6/8 (75.00%)  20 2/4 (50.00%)  11 0/0  0
Hyperkalemia  1  3/11 (27.27%)  10 2/8 (25.00%)  12 5/7 (71.43%)  12 7/15 (46.67%)  13 4/8 (50.00%)  7 1/4 (25.00%)  1 0/0  0
Hypermagnesemia  1  5/11 (45.45%)  7 4/8 (50.00%)  7 0/7 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hypernatremia  1  0/11 (0.00%)  0 1/8 (12.50%)  3 2/7 (28.57%)  2 3/15 (20.00%)  3 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Hyperuricemia  1  0/11 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  8 3/15 (20.00%)  3 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Hypoalbuminemia  1  11/11 (100.00%)  34 7/8 (87.50%)  57 6/7 (85.71%)  38 12/15 (80.00%)  66 8/8 (100.00%)  37 4/4 (100.00%)  13 0/0  0
Hypocalcemia  1  1/11 (9.09%)  2 1/8 (12.50%)  10 1/7 (14.29%)  5 7/15 (46.67%)  17 3/8 (37.50%)  10 1/4 (25.00%)  6 0/0  0
Hypoglycemia  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hypokalemia  1  1/11 (9.09%)  1 2/8 (25.00%)  2 1/7 (14.29%)  1 2/15 (13.33%)  5 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Hypomagnesemia  1  5/11 (45.45%)  7 4/8 (50.00%)  21 2/7 (28.57%)  3 5/15 (33.33%)  13 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Hyponatremia  1  8/11 (72.73%)  26 5/8 (62.50%)  11 7/7 (100.00%)  22 13/15 (86.67%)  45 8/8 (100.00%)  28 4/4 (100.00%)  11 0/0  0
Hypophosphatemia  1  2/11 (18.18%)  5 4/8 (50.00%)  23 4/7 (57.14%)  6 9/15 (60.00%)  37 4/8 (50.00%)  8 2/4 (50.00%)  3 0/0  0
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/15 (6.67%)  1 2/8 (25.00%)  2 1/4 (25.00%)  1 0/0  0
Back pain  1  4/11 (36.36%)  6 0/8 (0.00%)  0 1/7 (14.29%)  4 1/15 (6.67%)  3 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Chest wall pain  1  1/11 (9.09%)  2 0/8 (0.00%)  0 1/7 (14.29%)  1 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Musculoskeletal and connective tissue disorder - Other, (muscle twitching)  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Non-cardiac chest pain  1  5/11 (45.45%)  8 3/8 (37.50%)  4 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Tumor pain  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 3/15 (20.00%)  7 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Nervous system disorders               
Dizziness  1  2/11 (18.18%)  2 2/8 (25.00%)  2 1/7 (14.29%)  1 4/15 (26.67%)  4 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Dysgeusia  1  1/11 (9.09%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Encephalopathy  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Headache  1  1/11 (9.09%)  1 2/8 (25.00%)  2 1/7 (14.29%)  1 3/15 (20.00%)  4 2/8 (25.00%)  2 1/4 (25.00%)  1 0/0  0
Lethargy  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Nervous system disorders - Other, (vocal cord paralysis)  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Paresthesia  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Peripheral sensory neuropathy  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Somnolence  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 3/15 (20.00%)  3 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Tremor  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Vasovagal reaction  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Psychiatric disorders               
Anxiety  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  2 2/15 (13.33%)  2 2/8 (25.00%)  3 0/4 (0.00%)  0 0/0  0
Confusion  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Depression  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/15 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Insomnia  1  3/11 (27.27%)  3 1/8 (12.50%)  1 2/7 (28.57%)  2 6/15 (40.00%)  7 2/8 (25.00%)  3 1/4 (25.00%)  1 0/0  0
Restlessness  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Renal and urinary disorders               
Acute kidney injury  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  4 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Urinary frequency  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Urinary incontinence  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Urinary retention  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  2 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders               
Adult respiratory distress syndrome  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Allergic rhinitis  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Cough  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 5/15 (33.33%)  5 2/8 (25.00%)  2 1/4 (25.00%)  1 0/0  0
Dyspnea  1  3/11 (27.27%)  3 2/8 (25.00%)  2 3/7 (42.86%)  4 6/15 (40.00%)  8 3/8 (37.50%)  3 1/4 (25.00%)  1 0/0  0
Epistaxis  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hiccups  1  0/11 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hoarseness  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Hypoxia  1  0/11 (0.00%)  0 2/8 (25.00%)  4 1/7 (14.29%)  2 5/15 (33.33%)  9 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Laryngeal hemorrhage  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Nasal congestion  1  0/11 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  2 0/15 (0.00%)  0 2/8 (25.00%)  2 1/4 (25.00%)  1 0/0  0
Pleural effusion  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Pleuritic pain  1  2/11 (18.18%)  2 2/8 (25.00%)  2 2/7 (28.57%)  2 5/15 (33.33%)  12 1/8 (12.50%)  2 0/4 (0.00%)  0 0/0  0
Postnasal drip  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Productive cough  1  0/11 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/15 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders - Other, (tachypnea)  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Sore throat  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Wheezing  1  2/11 (18.18%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Skin and subcutaneous tissue disorders               
Alopecia  1  0/11 (0.00%)  0 2/8 (25.00%)  2 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Dry skin  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Erythroderma  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hyperhidrosis  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 2/15 (13.33%)  2 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Pruritus  1  1/11 (9.09%)  1 2/8 (25.00%)  2 0/7 (0.00%)  0 2/15 (13.33%)  2 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Rash acneiform  1  0/11 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Rash maculo-papular  1  1/11 (9.09%)  1 3/8 (37.50%)  3 0/7 (0.00%)  0 4/15 (26.67%)  4 1/8 (12.50%)  1 0/4 (0.00%)  0 0/0  0
Skin and subcutaneous tissue disorders - Other, specify  1 [1]  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Vascular disorders               
Capillary leak syndrome  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Flushing  1  0/11 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/4 (25.00%)  1 0/0  0
Hot flashes  1  0/11 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Hypertension  1  0/11 (0.00%)  0 3/8 (37.50%)  19 3/7 (42.86%)  5 6/15 (40.00%)  14 3/8 (37.50%)  6 0/4 (0.00%)  0 0/0  0
Hypotension  1  2/11 (18.18%)  2 3/8 (37.50%)  5 1/7 (14.29%)  2 8/15 (53.33%)  13 3/8 (37.50%)  4 0/4 (0.00%)  0 0/0  0
Superior vena cava syndrome  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
Thromboembolic event  1  1/11 (9.09%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/0  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Rash, face, upper torso
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. Raffit Hassan
Organization: National Cancer Institute
Phone: 301-451-8742
EMail: raffit_hassan@nih.gov
Layout table for additonal information
Responsible Party: Raffit Hassan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01362790    
Other Study ID Numbers: 110160
11-C-0160
First Submitted: May 27, 2011
First Posted: May 30, 2011
Results First Submitted: August 31, 2017
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019