ID

31021

Description

Study of Pegylated Human Recombinant Arginase for Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00988195

Link

https://clinicaltrials.gov/show/NCT00988195

Keywords

Versions (2)
  1. 7/11/18 7/11/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasm NCT00988195

English

Eligibility Neoplasm NCT00988195

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Neoplasm NCT00988195
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of hcc according to the european association for the study of the liver criteria
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
known underlying hcc etiology specified by hepatitis b, hepatitis c, post alcoholic cirrhosis, or other
Description

Liver carcinoma Etiology | Hepatitis B | Hepatitis C | Status post Alcoholic Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0023891
hcc lesion(s) which are not resectable and which are measurable by c-t scan
Description

Liver carcinoma Lesion unresectable | Measurable lesion CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1519810
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0040405
progression of or non-response of hcc lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
Description

Disease Progression | Liver carcinoma Lesion Unresponsive to Treatment | Status post Standard of Care best | Excision | Radiofrequency ablation | Chemoembolization

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C2936643
UMLS CUI [3,3]
C1522427
UMLS CUI [4]
C0728940
UMLS CUI [5]
C0850292
UMLS CUI [6]
C0796679
no cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
Description

Cancer treatment Absent | Operative Surgical Procedures Absent | Chemotherapy Absent | Biological treatment Targeted Absent | Enzyme Therapy Targeted Absent | Investigational Therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0596530
UMLS CUI [5,2]
C1521840
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0949266
UMLS CUI [6,2]
C0332197
males or females from 18 to 75 years-old, inclusive;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability and willingness to provide written informed consent;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
Description

Karnofsky Performance Status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
Description

Gender Urine pregnancy test negative | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a child-pugh score of c
Description

Liver Failure Advanced Child-Pugh Classification | Ascites Uncontrolled | Pleural effusion | Encephalopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0085605
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C2347612
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0032227
UMLS CUI [4]
C0085584
significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/l, evidence of bile duct obstruction, serum albumin <30 g/l, serum sgot >5 x upper limit of normal, anc <1.0 x 10^9/l, platelets <100 x 10^9/l, or inr >2.0
Description

Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction | Serum total bilirubin measurement | Cholestasis | Serum albumin measurement | Elevated SGOT | Absolute neutrophil count | Platelet Count measurement | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C3887504
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0008370
UMLS CUI [6]
C0523465
UMLS CUI [7]
C3150119
UMLS CUI [8]
C0948762
UMLS CUI [9]
C0032181
UMLS CUI [10]
C0525032
significant cardiac or pulmonary disease defined by new york heart association (nyha) class iii or iv, vef <50% by echo or muga, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ecg
Description

Heart Disease New York Heart Association Classification | Lung disease New York Heart Association Classification | Ventricular Ejection Fraction Echocardiography | Ventricular Ejection Fraction MUGA scan | Myocardial Infarction | Cardiac Arrhythmia Unstable Electrocardiography | Ischemia Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0042508
UMLS CUI [3,2]
C0013516
UMLS CUI [4,1]
C0042508
UMLS CUI [4,2]
C0521317
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0443343
UMLS CUI [6,3]
C1623258
UMLS CUI [7,1]
C0022116
UMLS CUI [7,2]
C1623258
pregnant or nursing women. note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
significant active infection including hiv requiring oral or parenteral anti-infective therapies;
Description

Communicable Disease | HIV Infection | Requirement Anti-infective therapy Oral | Requirement Anti-infective therapy Parenteral

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C1141958
UMLS CUI [3,3]
C1527415
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1141958
UMLS CUI [4,3]
C1518896
use of investigational drug(s) within 4 weeks of enrollment; or,
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
prior treatment with arginine depleting agent.
Description

Pharmaceutical Preparations Arginine Depletion

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0003765
UMLS CUI [1,3]
C0333668
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Similar models

Eligibility Neoplasm NCT00988195

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Neoplasm NCT00988195
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma
Item
confirmed diagnosis of hcc according to the european association for the study of the liver criteria
boolean
C2239176 (UMLS CUI [1])
Liver carcinoma Etiology | Hepatitis B | Hepatitis C | Status post Alcoholic Liver Cirrhosis
Item
known underlying hcc etiology specified by hepatitis b, hepatitis c, post alcoholic cirrhosis, or other
boolean
C2239176 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0023891 (UMLS CUI [4,2])
Liver carcinoma Lesion unresectable | Measurable lesion CT scan
Item
hcc lesion(s) which are not resectable and which are measurable by c-t scan
boolean
C2239176 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Disease Progression | Liver carcinoma Lesion Unresponsive to Treatment | Status post Standard of Care best | Excision | Radiofrequency ablation | Chemoembolization
Item
progression of or non-response of hcc lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
boolean
C0242656 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C1522427 (UMLS CUI [3,3])
C0728940 (UMLS CUI [4])
C0850292 (UMLS CUI [5])
C0796679 (UMLS CUI [6])
Cancer treatment Absent | Operative Surgical Procedures Absent | Chemotherapy Absent | Biological treatment Targeted Absent | Enzyme Therapy Targeted Absent | Investigational Therapy Absent
Item
no cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0596530 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0949266 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Age
Item
males or females from 18 to 75 years-old, inclusive;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability and willingness to provide written informed consent;
boolean
C0021430 (UMLS CUI [1])
Karnofsky Performance Status | Life Expectancy
Item
karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Gender Urine pregnancy test negative | Gender Contraceptive methods
Item
negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Liver Failure Advanced Child-Pugh Classification | Ascites Uncontrolled | Pleural effusion | Encephalopathy
Item
advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a child-pugh score of c
boolean
C0085605 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3])
C0085584 (UMLS CUI [4])
Liver Dysfunction | Renal dysfunction | Bone Marrow Dysfunction | Serum total bilirubin measurement | Cholestasis | Serum albumin measurement | Elevated SGOT | Absolute neutrophil count | Platelet Count measurement | International Normalized Ratio
Item
significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/l, evidence of bile duct obstruction, serum albumin <30 g/l, serum sgot >5 x upper limit of normal, anc <1.0 x 10^9/l, platelets <100 x 10^9/l, or inr >2.0
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C1278039 (UMLS CUI [4])
C0008370 (UMLS CUI [5])
C0523465 (UMLS CUI [6])
C3150119 (UMLS CUI [7])
C0948762 (UMLS CUI [8])
C0032181 (UMLS CUI [9])
C0525032 (UMLS CUI [10])
Heart Disease New York Heart Association Classification | Lung disease New York Heart Association Classification | Ventricular Ejection Fraction Echocardiography | Ventricular Ejection Fraction MUGA scan | Myocardial Infarction | Cardiac Arrhythmia Unstable Electrocardiography | Ischemia Electrocardiography
Item
significant cardiac or pulmonary disease defined by new york heart association (nyha) class iii or iv, vef <50% by echo or muga, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ecg
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0042508 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0042508 (UMLS CUI [4,1])
C0521317 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C1623258 (UMLS CUI [6,3])
C0022116 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
pregnant or nursing women. note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
Communicable Disease | HIV Infection | Requirement Anti-infective therapy Oral | Requirement Anti-infective therapy Parenteral
Item
significant active infection including hiv requiring oral or parenteral anti-infective therapies;
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C1141958 (UMLS CUI [3,2])
C1527415 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C1141958 (UMLS CUI [4,2])
C1518896 (UMLS CUI [4,3])
Investigational New Drugs
Item
use of investigational drug(s) within 4 weeks of enrollment; or,
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Arginine Depletion
Item
prior treatment with arginine depleting agent.
boolean
C0013227 (UMLS CUI [1,1])
C0003765 (UMLS CUI [1,2])
C0333668 (UMLS CUI [1,3])
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