Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

• Sponsor: Sherif S. Farag (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00593554
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Actual Duration (Months): 119.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia	Radiation: Total Body Irradiation; Drug: Thiotepa; Drug: Fludarabine; Biological: Rabbit ATG; Drug: Palifermin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
• Actual Study Start Date: Aug 7, 2007
• Actual Primary Completion Date: Aug 27, 2016
• Actual Study Completion Date: Jul 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;	Radiation: Total Body Irradiation; 8 Gy on Day -9; Drug: Thiotepa; 5 mg/kg/d on Day -8 to -7; Drug: Fludarabine; 40 mg/m2/d on Day -6 to -3; Biological: Rabbit ATG; 2.5 mg/kg/d on Day -5 to -2; Other Names: Antithymocyte globulin Thymoglobulin
Experimental: 2 Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG	Radiation: Total Body Irradiation; 8 Gy on Day -9; Drug: Thiotepa; 5 mg/kg/d on Day -8 to -7; Drug: Fludarabine; 40 mg/m2/d on Day -6 to -3; Biological: Rabbit ATG; 2.5 mg/kg/d on Day -5 to -2; Other Names: Antithymocyte globulin Thymoglobulin ; Drug: Palifermin; 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2; Other Names: Recombinant human keratinocyte growth factor Kepivance

Outcome Measures

Primary Outcome Measures

1. Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation [thru 6 months after transplant]

   To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.

Secondary Outcome Measures

1. Regimen-related Toxicity [Up to 1 year]

   The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.

2. Time to Neutrophil Engraftment [Transplant (Day 0) up to 1 year]

   Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.

3. Time to Platelet Engraftment [Transplant (Day 0) up to 1 year]

   Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

4. Acute Graft vs. Host Disease (GvHD) [Up to 1 year]

   Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.

5. Chronic Graft vs. Host Disease (GvHD) [Up to 1 year]

   Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.

6. Frequency of Infection [Day 0 through 1 year post transplantation]

   Number of unique patients with bacterial and/or viral infections reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria

• CR 1 with poor risk features

• CR 2, or higher order CR

• Acute lymphoblastic leukemia (ALL) with one of the following criteria

• CR 1 with poor risk features

• CR 2, or higher order CR

• Myelodysplasia, RAEB I

• Donor has been identified

• Age ≤ 65 years.

• Performance Status 0-1.

Exclusion Criteria:

• Patients relapsing <6 months after autologous SCT are not eligible.

• Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.

• Non-pregnant and non-nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Sherif S. Farag

Investigators

• Principal Investigator: Sherif Farag, MD/PhD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherif S. Farag, Lawrence H. Einhorn Professor of Oncology, Indiana University
• ClinicalTrials.gov Identifier: NCT00593554
• Other Study ID Numbers: 0704-19 IUCRO-0184
• First Posted: Jan 15, 2008
• Last Update Posted: Apr 10, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Fludarabine; Thiotepa; Thymoglobulin; Antilymphocyte Serum

Study Results

Participant Flow

Recruitment Details	This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Period Title: Overall Study
STARTED	3	5
COMPLETED	0	0
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin	Total
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2	Total of all reporting groups
Overall Participants	3	5	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	5 100%	8 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.6 (13.73)	45.9 (12.21)	44.6 (11.91)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 20%	1 12.5%
Male	3 100%	4 80%	7 87.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	3 100%	5 100%	8 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 33.3%	2 40%	3 37.5%
White	2 66.7%	3 60%	5 62.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
Description	To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
Time Frame	thru 6 months after transplant

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Number (95% Confidence Interval) [percentage of patients]	33	0

2. Secondary Outcome

Title	Regimen-related Toxicity
Description	The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Time to Neutrophil Engraftment
Description	Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Median (95% Confidence Interval) [days]	15	14

4. Secondary Outcome

Title	Time to Platelet Engraftment
Description	Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

Patients who received a transplant and who achieved platelet recovery/engraftment of platelets

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Median (95% Confidence Interval) [days]	22.5	20

5. Secondary Outcome

Title	Acute Graft vs. Host Disease (GvHD)
Description	Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Chronic Graft vs. Host Disease (GvHD)
Description	Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Frequency of Infection
Description	Number of unique patients with bacterial and/or viral infections reported.
Time Frame	Day 0 through 1 year post transplantation

Outcome Measure Data

Analysis Population Description

Patients who received a transplant

Arm/Group Title	Treatment Without Paliferim	Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Measure Participants	3	5
Count of Participants [Participants]	2 66.7%	5 100%

Adverse Events

Time Frame	Up to 1 year
Arm/Group Title	Treatment Without Paliferim		Treatment With Palifermin
Arm/Group Description	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2		Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
All Cause Mortality
	Treatment Without Paliferim		Treatment With Palifermin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment Without Paliferim		Treatment With Palifermin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/5 (20%)
General disorders
PAIN - OTHER	0/3 (0%)		1/5 (20%)
Infections and infestations
INFECTION - OTHER	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	0/3 (0%)		1/5 (20%)
Other (Not Including Serious) Adverse Events
	Treatment Without Paliferim		Treatment With Palifermin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		5/5 (100%)
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER	1/3 (33.3%)		0/5 (0%)
COAGULATION - OTHER	1/3 (33.3%)		0/5 (0%)
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE	1/3 (33.3%)		4/5 (80%)
LYMPHATICS - OTHER	1/3 (33.3%)		0/5 (0%)
THROMBOTIC MICROANGIOPATHY (E.G., THROMBOTIC THROMBOCYTOPENIC PURPURA [TTP] OR HEMOLYTIC UREMIC SYND	0/3 (0%)		1/5 (20%)
Cardiac disorders
CARDIAC GENERAL - OTHER	0/3 (0%)		1/5 (20%)
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION	0/3 (0%)		1/5 (20%)
PERICARDIAL EFFUSION (NON-MALIGNANT)	1/3 (33.3%)		1/5 (20%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION	1/3 (33.3%)		0/5 (0%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA	3/3 (100%)		4/5 (80%)
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA	0/3 (0%)		1/5 (20%)
Eye disorders
OCULAR/VISUAL - OTHER	1/3 (33.3%)		0/5 (0%)
VISION-BLURRED VISION	1/3 (33.3%)		1/5 (20%)
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)	1/3 (33.3%)		0/5 (0%)
CONSTIPATION	1/3 (33.3%)		2/5 (40%)
DIARRHEA	3/3 (100%)		5/5 (100%)
DISTENSION/BLOATING, ABDOMINAL	1/3 (33.3%)		0/5 (0%)
HEARTBURN/DYSPEPSIA	2/3 (66.7%)		0/5 (0%)
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)	0/3 (0%)		2/5 (40%)
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY	1/3 (33.3%)		2/5 (40%)
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - LARGE BOWEL	0/3 (0%)		1/5 (20%)
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY	2/3 (66.7%)		2/5 (40%)
NAUSEA	3/3 (100%)		5/5 (100%)
PAIN - ABDOMEN NOS	2/3 (66.7%)		3/5 (60%)
PAIN - ORAL CAVITY	0/3 (0%)		1/5 (20%)
PAIN - RECTUM	1/3 (33.3%)		0/5 (0%)
VOMITING	3/3 (100%)		5/5 (100%)
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER	0/3 (0%)		1/5 (20%)
EDEMA: LIMB	3/3 (100%)		5/5 (100%)
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	3/3 (100%)		5/5 (100%)
PAIN - OTHER	1/3 (33.3%)		2/5 (40%)
PAIN - PAIN NOS	0/3 (0%)		1/5 (20%)
RIGORS/CHILLS	0/3 (0%)		2/5 (40%)
Hepatobiliary disorders
BILIRUBIN (HYPERBILIRUBINEMIA)	3/3 (100%)		4/5 (80%)
CHOLECYSTITIS	0/3 (0%)		1/5 (20%)
HEPATOBILIARY/PANCREAS - OTHER	1/3 (33.3%)		0/5 (0%)
Infections and infestations
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)	1/3 (33.3%)		2/5 (40%)
INFECTION - OTHER	3/3 (100%)		3/5 (60%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)	0/3 (0%)		1/5 (20%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD	0/3 (0%)		1/5 (20%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS)	0/3 (0%)		1/5 (20%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS	0/3 (0%)		1/5 (20%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS	0/3 (0%)		1/5 (20%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - VAGINA	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)	0/3 (0%)		3/5 (60%)
INFECTION WITH UNKNOWN ANC - BLOOD	1/3 (33.3%)		3/5 (60%)
INFECTION WITH UNKNOWN ANC - CATHETER-RELATED	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - COLON	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - LIP/PERIORAL	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)	0/3 (0%)		1/5 (20%)
INFECTION WITH UNKNOWN ANC - SINUS	0/3 (0%)		2/5 (40%)
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS	0/3 (0%)		3/5 (60%)
Injury, poisoning and procedural complications
RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION	0/3 (0%)		1/5 (20%)
Investigations
ALKALINE PHOSPHATASE	3/3 (100%)		4/5 (80%)
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	3/3 (100%)		5/5 (100%)
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	3/3 (100%)		4/5 (80%)
CREATININE	2/3 (66.7%)		4/5 (80%)
Metabolism and nutrition disorders
DEHYDRATION	0/3 (0%)		4/5 (80%)
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER	1/3 (33.3%)		0/5 (0%)
PAIN - BACK	2/3 (66.7%)		2/5 (40%)
PAIN - BONE	0/3 (0%)		1/5 (20%)
PAIN - EXTREMITY-LIMB	1/3 (33.3%)		0/5 (0%)
PAIN - JOINT	0/3 (0%)		1/5 (20%)
PAIN - MUSCLE	0/3 (0%)		2/5 (40%)
Nervous system disorders
DIZZINESS	1/3 (33.3%)		1/5 (20%)
ENCEPHALOPATHY	1/3 (33.3%)		0/5 (0%)
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS	1/3 (33.3%)		0/5 (0%)
MEMORY IMPAIRMENT	0/3 (0%)		1/5 (20%)
NEUROPATHY: SENSORY	1/3 (33.3%)		3/5 (60%)
PAIN - HEAD/HEADACHE	2/3 (66.7%)		1/5 (20%)
Psychiatric disorders
CONFUSION	0/3 (0%)		1/5 (20%)
INSOMNIA	0/3 (0%)		1/5 (20%)
MENTAL STATUS	0/3 (0%)		2/5 (40%)
MOOD ALTERATION - DEPRESSION	0/3 (0%)		1/5 (20%)
Renal and urinary disorders
HEMORRHAGE, GU - BLADDER	0/3 (0%)		1/5 (20%)
HEMORRHAGE, GU - URINARY NOS	1/3 (33.3%)		0/5 (0%)
RENAL FAILURE	1/3 (33.3%)		0/5 (0%)
RENAL/GENITOURINARY - OTHER	1/3 (33.3%)		2/5 (40%)
Reproductive system and breast disorders
ERECTILE DYSFUNCTION	0/3 (0%)		1/5 (20%)
HEMORRHAGE, GU - VAGINA	0/3 (0%)		1/5 (20%)
IRREGULAR MENSES (CHANGE FROM BASELINE)	0/3 (0%)		1/5 (20%)
PAIN - PERINEUM	0/3 (0%)		1/5 (20%)
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)	1/3 (33.3%)		0/5 (0%)
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)	0/3 (0%)		1/5 (20%)
COUGH	1/3 (33.3%)		3/5 (60%)
DYSPNEA (SHORTNESS OF BREATH)	3/3 (100%)		4/5 (80%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	1/3 (33.3%)		1/5 (20%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS	0/3 (0%)		1/5 (20%)
HYPOXIA	2/3 (66.7%)		3/5 (60%)
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - PHARYNX	0/3 (0%)		1/5 (20%)
NASAL CAVITY/PARANASAL SINUS REACTIONS	0/3 (0%)		1/5 (20%)
PAIN - THROAT/PHARYNX/LARYNX	0/3 (0%)		1/5 (20%)
PLEURAL EFFUSION (NON-MALIGNANT)	2/3 (66.7%)		1/5 (20%)
PULMONARY/UPPER RESPIRATORY - OTHER	0/3 (0%)		2/5 (40%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER	1/3 (33.3%)		0/5 (0%)
HYPERPIGMENTATION	0/3 (0%)		1/5 (20%)
PRURITUS/ITCHING	0/3 (0%)		2/5 (40%)
RASH/DESQUAMATION	2/3 (66.7%)		2/5 (40%)
Vascular disorders
HYPERTENSION	0/3 (0%)		1/5 (20%)
HYPOTENSION	1/3 (33.3%)		1/5 (20%)
THROMBOSIS/THROMBUS/EMBOLISM	1/3 (33.3%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.