ID

10041

Description

ADVL0212: Eligibility Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/20/15 3/20/15 - Martin Dugas
Uploaded on

March 20, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Refractory tumors in children (NCT00053963)

English

No Instruction available.

1 forms  
  1. StudyEvent: ADVL0212: Eligibility Worksheet
    1. No Instruction available.
Header
Description

Header

Study Number
Description

Protocol ID COG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
COG Number
Description

PatientCOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C39353
UMLS 2011AA Property-2
C1516477
Patient's Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date worksheet entered into RDE
Description

DataEnteredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Eligibility criteria
Description

Eligibility criteria

Alias
UMLS CUI-1
C1516637
Is the planned start of treatment within seven days of fulfilling all eligibility criteria? (To be eligible, planned start of treatment must be within seven days of fulfilling all eligibility criteria.)
Description

TreatmentRequiredBeginDateInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25383
Is patient less than 22 years of age at the time of study entry? (To be eligible, patient must be less than 22 years of age at the time of study entry.)
Description

PatientRequiredAgeInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property-2
C25150
UMLS 2011AA Property-2
C0001779
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
Description

DiseaseHistologicDiagnosisInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is patient's disease considered refractory to conventional therapy, or is there no existing effective conventional therapy? (To be eligible, patient's disease must be considered refractory to conventional therapy, or there is no existing effective conventional therapy.)
Description

DiseaseTreatmentRefractoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15368
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
Description

CNSTumorNeurologicalDeficitStableInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C37940
UMLS 2011AA Property
C0011155
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
Description

KarnofskyPerformanceStatusScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C28013
NCI Thesaurus Property
C25365
UMLS CUI-1
C0206065
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
Description

LanskyPerformanceStatusScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Does patient have a life expectancy of greater than or equal to 8 weeks? (To be eligible, the patient must have a life expectancy of greater than or equal to 8 weeks.)
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C37987
NCI Thesaurus Property-2
C25171
NCI Thesaurus Property-3
C25359
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0023671
UMLS CUI-2
C1442456
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study? (Myleosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study 4 weeks if prior nitrosourea.)
Description

PatientRecoveryEligibilityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
Did patient receive growth factors within 1 week of entry onto this study? (To be eligible, patient must not have received growth factors within 1 week of entry onto this study.)
Description

PriorGrowthFactorReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C20424
UMLS 2011AA ObjectClass-2
C0018284
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
Description

DexamethasoneAgentDoseStableInd

Data type

text

Alias
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Is patient receiving enzyme-inducing anticonvulsant drugs? (To be eligible, patient must not be receiving enzyme-inducing anticonvulsant drugs.)
Description

AnticonvulsantMedicationReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
Does patient have adequate bone marrow function? (To be eligible, patient must have adequate bone marrow function as defined below:)
Description

PatientBoneMarrowFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate renal function? (To be eligible, patient must have adequate renal function as defined below:)
Description

PatientRenalFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate liver function? (To be eligible, patient must have adequate liver function as defined below:)
Description

PatientLiverFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate cardiac function? (To be eligible, patient must have adequate cardiac function as defined below:)
Description

PatientCardiacFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate pulmonary function? (To be eligible, patient must have adequate pulmonary function as defined below:)
Description

PatientPulmonaryFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate central nervous system function? (To be eligible, patient must have adequate central nervous system function as defined below:)
Description

PatientCNSFunctionRequiredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
Description

PatientPregnancyTestInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25742
UMLS CUI-1
C0032976
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
Description

ContraceptionAgreementInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Does patient have an uncontrolled infection? (To be eligible, patient must not have an uncontrolled infection.)
Description

PatientInfectionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Has patient previously received depsipeptide? (To be eligible, patient must not have previously received depsipeptide.)
Description

AgentReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Does patient have the following: Symptoms of congestive heart failure, Uncontrolled cardiac rhythm disturbance, or QTC that is greater than or equal to 480 msec (To be eligible, patient must not have any of the above characteristics.)
Description

PatientRequiredCharacteristicsCOGInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25447
UMLS 2011AA Property
C1521970
Has the patient and/or the parents or legal guardians signed a written informed consent? (To be eligible, the patient and/or the parents or legal guardians must have signed a written informed consent.)
Description

InformedConsentFormSignedDate

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI-1
C0021430
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must have been met.)
Description

StudyCompleteRequirementsInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C38015
Dose level/duration assignment (To be assigned via RDE at the time of study entry.)
Description

TreatmentAssignmentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
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1 forms
  1. StudyEvent: ADVL0212: Eligibility Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientCOGIdentifierNumber
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Eligibility criteria
C1516637 (UMLS CUI-1)
TreatmentRequiredBeginDateInd-2
Item
Is the planned start of treatment within seven days of fulfilling all eligibility criteria? (To be eligible, planned start of treatment must be within seven days of fulfilling all eligibility criteria.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25383 (NCI Thesaurus Property)
PatientRequiredAgeInd-2
Item
Is patient less than 22 years of age at the time of study entry? (To be eligible, patient must be less than 22 years of age at the time of study entry.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
Item
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.3
Code List
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Patient Has Either A Brain Stem Or Optic Pathway Tumor (Patient has either a brain stem or optic pathway tumor)
DiseaseTreatmentRefractoryInd-2
Item
Is patient's disease considered refractory to conventional therapy, or is there no existing effective conventional therapy? (To be eligible, patient's disease must be considered refractory to conventional therapy, or there is no existing effective conventional therapy.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Item
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C37940 (NCI Thesaurus Property)
C0011155 (UMLS 2011AA Property)
CL.5
Code List
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Does Not Have A Cns Tumor (N/A, patient does not have a CNS tumor)
Item
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
text
C25664 (NCI Thesaurus ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0206065 (UMLS CUI-1)
CL.6
Code List
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
CL Item
Normal, no complaints, no evidence of disease (100)
CL Item
Able to carry on normal activity, minor signs or symptoms of disease (90)
CL Item
Normal activity with effort, some signs or symptoms of disease (80)
CL Item
Cares for self. Unable to carry on normal activity or to do active work (70)
CL Item
Requires occasional assistance, but is able to care for most of own needs (60)
CL Item
Requires considerable assistance and frequent medical care (50)
CL Item
Disabled, requires special care and assistance (40)
CL Item
Severely disabled, hospitalization is indicated although death is not imminent (30)
CL Item
Hospitalization necessary, very sick, active supportive treatment necessary (20)
CL Item
Moribund, fatal processes progressing rapidly (10)
CL Item
Dead (0)
Item
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
CL Item
100 (100 - Fully active, normal)
CL Item
90 (90 - Minor restrictions in physically strenuous activity)
CL Item
80 (80 - Active, but tires more quickly)
CL Item
70 (70 - Both greater restriction of and less time spent in play activity)
CL Item
60 (60 - Up and around, but minimal active play; keeps busy with quieter activities)
CL Item
50 (50 - Gets dressed but lies around much of the day, no active play, able to participate in all quiet play and activities)
CL Item
40 (40 - Mostly in bed; participates in quiet activities)
CL Item
30 (30 - In bed; needs assistance even for quiet play)
CL Item
20 (20 - Often sleeping; play entirely limited to very passive activities)
CL Item
10 (10 - No play; does not get out of bed)
CL Item
0 (0 - Unresponsive)
C0919414 (NCI Metathesaurus)
life expectancy 8 weeks
Item
Does patient have a life expectancy of greater than or equal to 8 weeks? (To be eligible, the patient must have a life expectancy of greater than or equal to 8 weeks.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C37987 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25359 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0023671 (UMLS CUI-1)
C1442456 (UMLS CUI-2)
PatientRecoveryEligibilityInd-2
Item
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study? (Myleosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study 4 weeks if prior nitrosourea.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
PriorGrowthFactorReceivedInd-2
Item
Did patient receive growth factors within 1 week of entry onto this study? (To be eligible, patient must not have received growth factors within 1 week of entry onto this study.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C20424 (NCI Thesaurus ObjectClass-2)
C0018284 (UMLS 2011AA ObjectClass-2)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Item
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL.11
Code List
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Does Not Have A Cns Tumor (N/A, patient does not have a CNS tumor)
CL Item
N/a, Patient Has Cns Tumor, But Is Not Receiving Dexamethasone (N/A, patient has a CNS tumor, but it not receiving dexamethasone)
AnticonvulsantMedicationReceivedInd-2
Item
Is patient receiving enzyme-inducing anticonvulsant drugs? (To be eligible, patient must not be receiving enzyme-inducing anticonvulsant drugs.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does patient have adequate bone marrow function? (To be eligible, patient must have adequate bone marrow function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientRenalFunctionRequiredInd-2
Item
Does patient have adequate renal function? (To be eligible, patient must have adequate renal function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientLiverFunctionRequiredInd-2
Item
Does patient have adequate liver function? (To be eligible, patient must have adequate liver function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientCardiacFunctionRequiredInd-2
Item
Does patient have adequate cardiac function? (To be eligible, patient must have adequate cardiac function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientPulmonaryFunctionRequiredInd-2
Item
Does patient have adequate pulmonary function? (To be eligible, patient must have adequate pulmonary function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientCNSFunctionRequiredInd-2
Item
Does patient have adequate central nervous system function? (To be eligible, patient must have adequate central nervous system function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
text
C16960 (NCI Thesaurus ObjectClass)
C25742 (NCI Thesaurus Property)
C0032976 (UMLS CUI-1)
CL.19
Code List
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Is Female, But Not Post-menarchal (N/A, patient is female, but not post-menarchal)
CL Item
N/a, Patient Is Male (N/A, patient is male)
Item
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.20
Code List
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/A, patient is not of reproductive potential (N/A, patient is not of reproductive potential)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientInfectionInd-2
Item
Does patient have an uncontrolled infection? (To be eligible, patient must not have an uncontrolled infection.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
AgentReceivedInd-2
Item
Has patient previously received depsipeptide? (To be eligible, patient must not have previously received depsipeptide.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
PatientRequiredCharacteristicsCOGInd-2
Item
Does patient have the following: Symptoms of congestive heart failure, Uncontrolled cardiac rhythm disturbance, or QTC that is greater than or equal to 480 msec (To be eligible, patient must not have any of the above characteristics.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25447 (NCI Thesaurus Property)
C1521970 (UMLS 2011AA Property)
Informed Consent
Item
Has the patient and/or the parents or legal guardians signed a written informed consent? (To be eligible, the patient and/or the parents or legal guardians must have signed a written informed consent.)
boolean
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C0021430 (UMLS CUI-1)
StudyCompleteRequirementsInd-2
Item
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must have been met.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
TreatmentAssignmentText
Item
Dose level/duration assignment (To be assigned via RDE at the time of study entry.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
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