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Trial record 7 of 8 for:    "Non-Langerhans-Cell Histiocytosis" | "Antibiotics, Antitubercular"

Stem Cell Transplant for Immunologic or Histiocytic Disorders

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: NCT00176865
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : April 14, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hemophagocytic Lymphohistiocytosis
X-Linked Lymphoproliferative Disorders
Chediak-Higashi Syndrome
Griscelli Syndrome
Immunologic Deficiency Syndromes
Langerhans-Cell Histiocytosis
Interventions Procedure: Stem Cell Transplant
Drug: Fludarabine
Drug: Melphalan
Drug: Anti-thymocyte globulin (ATG)
Drug: Campath 1H
Drug: Cyclosporin A
Drug: Mycophenolate mofetil
Drug: Intravenous immunoglobulin (IVIG)
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Period Title: Overall Study
Started 3 10 6
Completed 3 10 6
Not Completed 0 0 0
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors Total
Hide Arm/Group Description

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Total of all reporting groups
Overall Number of Baseline Participants 3 10 6 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 6 participants 19 participants
<=18 years
3
 100.0%
10
 100.0%
6
 100.0%
19
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 6 participants 19 participants
Female
1
  33.3%
3
  30.0%
3
  50.0%
7
  36.8%
Male
2
  66.7%
7
  70.0%
3
  50.0%
12
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 10 participants 6 participants 19 participants
3 10 6 19
1.Primary Outcome
Title Number of Subjects With Mixed Chimerism
Hide Description >10% Donor Cells at Day 100
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description

Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.

Arm 3: 2 of 6 patients not evaluable due to early death.

Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 8 4
Measure Type: Number
Unit of Measure: participants
3 8 4
2.Secondary Outcome
Title Percentage of Donor Chimerism at 100 Days
Hide Description The percent of recipient bone marrow and blood cells that are of donor origin.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description

Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.

Arm 3: 2 of 6 patients not evaluable due to early death.

Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 8 4
Mean (Standard Deviation)
Unit of Measure: percentage of donor cells
96.5  (6.0) 75.5  (37.3) 100  (0)
3.Secondary Outcome
Title Percentage of Donor Chimerism at 180 Days
Hide Description The percent of recipient bone marrow and blood cells that are of donor origin.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description

Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.

Arm 3: 2 of 6 patients not evaluable due to early death.

Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 8 4
Mean (Standard Deviation)
Unit of Measure: percentage of donor cells
88.9  (19.2) 73.3  (41.7) 90.5  (16.4)
4.Secondary Outcome
Title Percentage of Donor Chimerism at 365 Days
Hide Description The percent of recipient bone marrow and blood cells that are of donor origin.
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description

Arm 2: 2 of 10 patients not evaluable due to failure to return to clinic for the Day 100 evaluation.

Arm 3: 2 of 6 patients not evaluable due to early death.

Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 8 4
Mean (Standard Deviation)
Unit of Measure: percentage of donor cells
81.9  (31.4) 78.6  (38.2) 91.7  (13.5)
5.Secondary Outcome
Title Incidence of Grade 2-4 Acute Graft Versus Host Disease (aGVHD)
Hide Description Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 10 6
Measure Type: Number
Unit of Measure: participants
1 3 0
6.Secondary Outcome
Title Incidence of Grade 3-4 Acute Graft Versus Host Disease (aGVHD)
Hide Description Acute graft versus host disease (aGVHD) is a reaction occurring within the first 100 days after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs. The severity of aGVHD is graded on a scale of 1 - 4 with the highest number representing the most severe disease.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 10 6
Measure Type: Number
Unit of Measure: participants
1 1 0
7.Secondary Outcome
Title Incidence of Chronic Graft Versus Host Disease (cGVHD)
Hide Description Chronic graft versus host disease (cGVHD) is a reaction which typically develops 3 to 6 months after transplant where the T- cells of the donor graft attacks the recipient's (host's) skin, GI tract, liver and other organs.
Time Frame 6 months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 10 6
Measure Type: Number
Unit of Measure: participants
1 0 0
8.Secondary Outcome
Title Number of Subjects Alive at 100 Days
Hide Description [Not Specified]
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 10 6
Measure Type: Number
Unit of Measure: participants
3 8 4
9.Secondary Outcome
Title Number of Subjects Alive at One Year
Hide Description [Not Specified]
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 3 10 6
Measure Type: Number
Unit of Measure: participants
3 7 3
10.Secondary Outcome
Title Compare Quality of Life (QOL)
Hide Description [Not Specified]
Time Frame Pretransplant, 1 year, 2 years and 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
PI made decision after IRB approval, but before opening the study to accrual, to not collect QOL data .
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description:

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Hide Arm/Group Description

human leukocyte antigen (HLA) genotypic matched sibling donor

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells

Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day

All-Cause Mortality
Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/10 (10.00%)   0/6 (0.00%) 
General disorders       
Multi-organ failure  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 - Matched Sibling Donor Arm 2 - Matched Unrelated Donor Arm 3 - Mismatched Double Cord Donors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   10/10 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders       
Coagulopathy  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Hemolytic anemia  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Cardiac disorders       
Hypertension  1/3 (33.33%)  4/10 (40.00%)  1/6 (16.67%) 
Pericardial effusion  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Prolonged QTC interval  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Cardiomegaly  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Ear and labyrinth disorders       
Hearing loss  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Ear drainage  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Endocrine disorders       
Delayed growth  1/3 (33.33%)  2/10 (20.00%)  0/6 (0.00%) 
Hypothyroidism  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Syndrome of inappropriate antidiuretic hormone secretion  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Eye disorders       
Incipient cataracts, bilateral  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
GI bleed  0/3 (0.00%)  2/10 (20.00%)  1/6 (16.67%) 
Colonic pneumatosis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Hemorrhagic gastritis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Mucositis  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Pancreatitis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Hepatobiliary disorders       
Liver failure  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Veno-occlusive disease  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Cholestasis portal fibrosis and bile duct proliferation  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Infections and infestations       
Infection, GI  1/3 (33.33%)  3/10 (30.00%)  2/6 (33.33%) 
Infection, blood  1/3 (33.33%)  7/10 (70.00%)  1/6 (16.67%) 
Infection, respiratory  1/3 (33.33%)  8/10 (80.00%)  5/6 (83.33%) 
Infection, skin  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Infection, GU  0/3 (0.00%)  3/10 (30.00%)  1/6 (16.67%) 
Otitis  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Infection, NOS  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Investigations       
Hyperbilirubinemia  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Elevated liver function tests  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
Hyperglycemia  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Malnutrition  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Prerenal azotemia  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Nervous system disorders       
Seizure  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Intraparenchymal hemorrhage, left frontal lobe  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Learning dysfunction  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Psychiatric disorders       
Delirious  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Anxiety  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Hallucinations  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
Psychosis  1/3 (33.33%)  0/10 (0.00%)  0/6 (0.00%) 
ICU dementia  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Renal and urinary disorders       
Cystitis  1/3 (33.33%)  2/10 (20.00%)  0/6 (0.00%) 
Acute renal failure  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Hemorrhagic cystitis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary hemorrhage  1/3 (33.33%)  2/10 (20.00%)  0/6 (0.00%) 
Pulmonary hypertension  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Respiratory failure  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Respiratory distress and apnea  0/3 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
Erythrodermic dermatitis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Skin breakdown  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Vascular disorders       
Capillary leak  0/3 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Subclavian thrombosis  0/3 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
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. Angela Smith
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-2778
EMail: smith719@umn.edu
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00176865     History of Changes
Other Study ID Numbers: MT2002-12
0207M29448 ( Other Identifier: IRB, University of Minnesota )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: May 6, 2015
Results First Posted: April 14, 2017
Last Update Posted: December 28, 2017