ID

40809

Beschreibung

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01938833

Link

https://clinicaltrials.gov/show/NCT01938833

Stichworte

Versionen (1)
  1. 17.05.20 17.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. Mai 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility HER2-negative Breast Cancer NCT01938833

Englisch

Eligibility HER2-negative Breast Cancer NCT01938833

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of ibc based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
Beschreibung

Breast Carcinoma | Inflammatory Breast Carcinoma | Erythema diffuse | Edema | Peau d'orange surface of breast | Breast palpable mass | Breast palpable mass Absent | Lymphatic Invasion Dermal

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0278601
UMLS CUI [3]
C0858689
UMLS CUI [4]
C0013604
UMLS CUI [5]
C0425791
UMLS CUI [6]
C1403543
UMLS CUI [7,1]
C1403543
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C1708790
UMLS CUI [8,2]
C0221928
2. patients may have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with recist criteria v. 1.1 as described in detail in section 11.0 or non-measurable tumors
Beschreibung

Measurable lesion Quantity | Measurable lesion Dimension Quantity | Non-Measurable Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C1334988
3. patients must have demonstrated metastatic disease and not received >2 lines of systemic therapy for metastatic disease
Beschreibung

Neoplasm Metastasis | Systemic therapy Line Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C4524693
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0027627
4. age > 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status 0, 1 or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. patients must have normal organ and marrow function as defined below: a) leukocytes > 2,500/mcl b) absolute neutrophil count > 1,500/mcl c) hemoglobin > 9 g/dl d) platelets > 100,000/mcl e) total bilirubin < 1.5 mg/dl f) ast/alt (sgot/sgpt) < 2.5 x uln g) alkaline phosphatase < 2.5 x uln (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x uln would be acceptable. h) serum magnesium > 1.8 mg/dl i) serum creatinine < 1.5 mg/dl j) serum potassium > 3.8 mmol/l
Beschreibung

Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Absent | Serum magnesium measurement | Creatinine measurement, serum | Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0032181
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201850
UMLS CUI [11]
C0153690
UMLS CUI [12,1]
C0494165
UMLS CUI [12,2]
C0332197
UMLS CUI [13]
C0202125
UMLS CUI [14]
C0201976
UMLS CUI [15]
C0302353
7. tumor negative for her2 expression (0 or 1+ by ihc) or negative fish testing
Beschreibung

Tumor HER2 Negative Immunohistochemistry | Tumor FISH test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C1513916
8. patients must have a life expectancy of at least 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
9. patients must be recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Beschreibung

Effects of Prior surgery | Effects of Prior radiation therapy | Effects of Antineoplastic Drug/Agent Therapy | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C0455610
UMLS CUI [2,1]
C1704420
UMLS CUI [2,2]
C0279134
UMLS CUI [3,1]
C1704420
UMLS CUI [3,2]
C2346834
UMLS CUI [4]
C1115804
10. patients must have < grade 2 pre-existing peripheral neuropathy per ctcae
Beschreibung

Peripheral Neuropathy Pre-existing CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
11. women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Beschreibung

Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
12. negative serum or urine β-hcg pregnancy test at screening, performed no more than 72 hours prior to treatment initiation; for patients of childbearing potential
Beschreibung

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative HCG beta

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [2,3]
C0106132
13. ability to understand and willingness to sign a written informed consent and hipaa consent document
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse event from agents administered more than 4 weeks earlier
Beschreibung

Chemotherapy Recent | Therapeutic radiology procedure Recent | Adverse reaction to drug | Recovery Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332185
UMLS CUI [3]
C0041755
UMLS CUI [4,1]
C2004454
UMLS CUI [4,2]
C0332268
2. patients may not be receiving any other investigational agents or active anti-neoplastic therapies
Beschreibung

Investigational New Drugs | Antineoplastic Drug/Agent Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346834
3. patients who have previously received romidepsin or abraxane
Beschreibung

romidepsin | Abraxane

Datentyp

boolean

Alias
UMLS CUI [1]
C1527027
UMLS CUI [2]
C1564985
4. patients with untreated or uncontrolled brain metastases or leptomeningeal disease
Beschreibung

Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Uncontrolled | Leptomeningeal disease untreated | Leptomeningeal disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0751297
UMLS CUI [3,2]
C0332155
UMLS CUI [4,1]
C0751297
UMLS CUI [4,2]
C0205318
5. patients with known hypersensitivity to any of the components of romidepsin or who have had hypersensitivity reactions to paclitaxel
Beschreibung

Hypersensitivity Component Romidepsin | Paclitaxel allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C1527027
UMLS CUI [2]
C0570707
6. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
7. any known cardiac abnormalities such as:
Beschreibung

Cardiac abnormality

Datentyp

boolean

Alias
UMLS CUI [1]
C0018798
1. congenital long qt syndrome
Beschreibung

Congenital long QT syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1141890
2. qtc interval ≥ 500 milliseconds
Beschreibung

Prolonged QTc interval

Datentyp

boolean

Alias
UMLS CUI [1]
C1560305
3. myocardial infarction within 6 months of c1d1. subjects with a history of myocardial infarction between 6 and 12 months prior to c1d1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
4. other significant ekg abnormalities including 2nd degree atrio-ventricular (av) block type ii, 3rd degree av block, or bradycardia (ventricular rate less than 50 beats/min)
Beschreibung

ECG abnormal | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0264906
UMLS CUI [3]
C0151517
UMLS CUI [4]
C0428977
UMLS CUI [5]
C1883530
5. symptomatic coronary artery disease (cad), e.g., angina canadian class ii-iv (see appendix iii) in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
Beschreibung

Coronary Artery Disease Symptomatic | Angina Pectoris Canadian Cardiovascular Society classification of angina

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C1277207
6. an ekg recorded at screening showing evidence of cardiac ischemia (st depression depression of ≥2 mm, measured from isoelectric line to the st segment). if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
Beschreibung

Myocardial Ischemia ECG | ST segment depression ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C1623258
UMLS CUI [2,1]
C0520887
UMLS CUI [2,2]
C1623258
7. congestive heart failure (chf) that meets new york heart association (nyha) class ii to iv definitions (see appendix iv) and/or known ejection fraction <40% by muga or <50% by echocardiogram and/ormri
Beschreibung

Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0013516
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C0024485
8. a known history of sustained ventricular tachycardia (vt), ventricular fibrillation (vf), torsade de pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (aicd)
Beschreibung

Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Cardiac Arrest | Exception Automatic Implantable Cardioverter-Defibrillator

Datentyp

boolean

Alias
UMLS CUI [1]
C0750197
UMLS CUI [2]
C0042510
UMLS CUI [3]
C0040479
UMLS CUI [4]
C0018790
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0972395
9. hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
Beschreibung

Hypertrophic cardiomegaly Due to Prior Therapy | Restrictive cardiomyopathy Due to Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733179
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C0007196
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514463
10. uncontrolled hypertension, i.e., blood pressure (bp) of ≥ 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
Beschreibung

Uncontrolled hypertension | Blood pressure determination

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
11. any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
Beschreibung

Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003195
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304516
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
12. patients taking drugs leading to significant qt prolongation (see appendix i: medications that may cause qtc prolongation)
Beschreibung

Pharmaceutical Preparations Causing Prolonged QT interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
13. concomitant use of cyp3a4 inhibitors (see appendix ii)
Beschreibung

CYP3A4 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C3850053
8. patients with known hiv, hepatitis b or c (however, if patients have previously been treated for hepatitis b or c and have undetectable viral loads, they can be considered eligible for trial)
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
9. pregnant or breast feeding. refer to section 4.4 for further detail
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. patients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Beschreibung

Other medical condition Interferes with Informed Consent | Mental condition Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0459471
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0459471
UMLS CUI [8,4]
C0683954
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Ähnliche Modelle

Eligibility HER2-negative Breast Cancer NCT01938833

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Inflammatory Breast Carcinoma | Erythema diffuse | Edema | Peau d'orange surface of breast | Breast palpable mass | Breast palpable mass Absent | Lymphatic Invasion Dermal
Item
1. patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of ibc based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
boolean
C0678222 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0858689 (UMLS CUI [3])
C0013604 (UMLS CUI [4])
C0425791 (UMLS CUI [5])
C1403543 (UMLS CUI [6])
C1403543 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C1708790 (UMLS CUI [8,1])
C0221928 (UMLS CUI [8,2])
Measurable lesion Quantity | Measurable lesion Dimension Quantity | Non-Measurable Lesion
Item
2. patients may have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with recist criteria v. 1.1 as described in detail in section 11.0 or non-measurable tumors
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1334988 (UMLS CUI [3])
Neoplasm Metastasis | Systemic therapy Line Quantity Neoplasm Metastasis
Item
3. patients must have demonstrated metastatic disease and not received >2 lines of systemic therapy for metastatic disease
boolean
C0027627 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C4524693 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0027627 (UMLS CUI [2,4])
Age
Item
4. age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Absent | Serum magnesium measurement | Creatinine measurement, serum | Serum potassium measurement
Item
6. patients must have normal organ and marrow function as defined below: a) leukocytes > 2,500/mcl b) absolute neutrophil count > 1,500/mcl c) hemoglobin > 9 g/dl d) platelets > 100,000/mcl e) total bilirubin < 1.5 mg/dl f) ast/alt (sgot/sgpt) < 2.5 x uln g) alkaline phosphatase < 2.5 x uln (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x uln would be acceptable. h) serum magnesium > 1.8 mg/dl i) serum creatinine < 1.5 mg/dl j) serum potassium > 3.8 mmol/l
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201850 (UMLS CUI [10])
C0153690 (UMLS CUI [11])
C0494165 (UMLS CUI [12,1])
C0332197 (UMLS CUI [12,2])
C0202125 (UMLS CUI [13])
C0201976 (UMLS CUI [14])
C0302353 (UMLS CUI [15])
Tumor HER2 Negative Immunohistochemistry | Tumor FISH test Negative
Item
7. tumor negative for her2 expression (0 or 1+ by ihc) or negative fish testing
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Life Expectancy
Item
8. patients must have a life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Effects of Prior surgery | Effects of Prior radiation therapy | Effects of Antineoplastic Drug/Agent Therapy | Patient recovered
Item
9. patients must be recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
boolean
C1704420 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
C1704420 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
C1704420 (UMLS CUI [3,1])
C2346834 (UMLS CUI [3,2])
C1115804 (UMLS CUI [4])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
10. patients must have < grade 2 pre-existing peripheral neuropathy per ctcae
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
11. women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative HCG beta
Item
12. negative serum or urine β-hcg pregnancy test at screening, performed no more than 72 hours prior to treatment initiation; for patients of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0106132 (UMLS CUI [2,3])
Informed Consent
Item
13. ability to understand and willingness to sign a written informed consent and hipaa consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Recent | Therapeutic radiology procedure Recent | Adverse reaction to drug | Recovery Lacking
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse event from agents administered more than 4 weeks earlier
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0041755 (UMLS CUI [3])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Investigational New Drugs | Antineoplastic Drug/Agent Therapy
Item
2. patients may not be receiving any other investigational agents or active anti-neoplastic therapies
boolean
C0013230 (UMLS CUI [1])
C2346834 (UMLS CUI [2])
romidepsin | Abraxane
Item
3. patients who have previously received romidepsin or abraxane
boolean
C1527027 (UMLS CUI [1])
C1564985 (UMLS CUI [2])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Uncontrolled | Leptomeningeal disease untreated | Leptomeningeal disease Uncontrolled
Item
4. patients with untreated or uncontrolled brain metastases or leptomeningeal disease
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0751297 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0751297 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Hypersensitivity Component Romidepsin | Paclitaxel allergy
Item
5. patients with known hypersensitivity to any of the components of romidepsin or who have had hypersensitivity reactions to paclitaxel
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C1527027 (UMLS CUI [1,3])
C0570707 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
6. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Cardiac abnormality
Item
7. any known cardiac abnormalities such as:
boolean
C0018798 (UMLS CUI [1])
Congenital long QT syndrome
Item
1. congenital long qt syndrome
boolean
C1141890 (UMLS CUI [1])
Prolonged QTc interval
Item
2. qtc interval ≥ 500 milliseconds
boolean
C1560305 (UMLS CUI [1])
Myocardial Infarction
Item
3. myocardial infarction within 6 months of c1d1. subjects with a history of myocardial infarction between 6 and 12 months prior to c1d1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
boolean
C0027051 (UMLS CUI [1])
ECG abnormal | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate
Item
4. other significant ekg abnormalities including 2nd degree atrio-ventricular (av) block type ii, 3rd degree av block, or bradycardia (ventricular rate less than 50 beats/min)
boolean
C0522055 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0428977 (UMLS CUI [4])
C1883530 (UMLS CUI [5])
Coronary Artery Disease Symptomatic | Angina Pectoris Canadian Cardiovascular Society classification of angina
Item
5. symptomatic coronary artery disease (cad), e.g., angina canadian class ii-iv (see appendix iii) in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C1277207 (UMLS CUI [2,2])
Myocardial Ischemia ECG | ST segment depression ECG
Item
6. an ekg recorded at screening showing evidence of cardiac ischemia (st depression depression of ≥2 mm, measured from isoelectric line to the st segment). if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
boolean
C0151744 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0520887 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MRI
Item
7. congestive heart failure (chf) that meets new york heart association (nyha) class ii to iv definitions (see appendix iv) and/or known ejection fraction <40% by muga or <50% by echocardiogram and/ormri
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0232174 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Cardiac Arrest | Exception Automatic Implantable Cardioverter-Defibrillator
Item
8. a known history of sustained ventricular tachycardia (vt), ventricular fibrillation (vf), torsade de pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (aicd)
boolean
C0750197 (UMLS CUI [1])
C0042510 (UMLS CUI [2])
C0040479 (UMLS CUI [3])
C0018790 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0972395 (UMLS CUI [5,2])
Hypertrophic cardiomegaly Due to Prior Therapy | Restrictive cardiomyopathy Due to Prior Therapy
Item
9. hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
boolean
C2733179 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0007196 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
Uncontrolled hypertension | Blood pressure determination
Item
10. uncontrolled hypertension, i.e., blood pressure (bp) of ≥ 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists Dose Stable
Item
11. any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
12. patients taking drugs leading to significant qt prolongation (see appendix i: medications that may cause qtc prolongation)
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
CYP3A4 Inhibitors
Item
13. concomitant use of cyp3a4 inhibitors (see appendix ii)
boolean
C3850053 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
8. patients with known hiv, hepatitis b or c (however, if patients have previously been treated for hepatitis b or c and have undetectable viral loads, they can be considered eligible for trial)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
9. pregnant or breast feeding. refer to section 4.4 for further detail
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other medical condition Interferes with Informed Consent | Mental condition Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results
Item
10. patients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
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