ID

12114

Description

COG ADVL0912 OPEN Registration Worksheet NCT00939770 Crizotinib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A54DD196-B288-B398-E040-BB89AD432E23

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A54DD196-B288-B398-E040-BB89AD432E23

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 9/24/15 9/24/15 - Martin Dugas
Uploaded on

September 24, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Registration Brain and Central Nervous System Tumors COG ADVL0912 NCT00939770

English

No Instruction available.

1 forms  
  1. StudyEvent: COG ADVL0912 OPEN Registration Worksheet
    1. No Instruction available.
Stratification
Description

Stratification

ADVL0912 Stratum
Description

ClinicalStudyProtocolStratificationFactorsType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C16153
UMLS 2011AA Property
C1514984
Treatment Start Date
Description

TreatmentBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Patient Criteria
Description

Patient Criteria

Were tests to determine eligibility performed during the indicated period (Indicated period refers to prior to enrollment. - - Note: All studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Please see section 4.0 of the protocol for instructions on required repeated eligibility studies if more than 7 calendar days elapse between labs and start of therapy. - )
Description

PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-3
C0022885
NCI Thesaurus Property-4
C25171
UMLS 2011AA Property-4
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the patient in the indicated age range at time of study enrollment (To be eligible, patient must be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.)
Description

PatientAgeEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Does patient have a BSA (body surface area) greater than or equal to the indicated value (BSA Dose Level 0 and 1 only: To be eligible, patients must have a BSA >= 0.4 at the time of study enrollment. - )
Description

PersonGreaterBodySurfaceAreaClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C61421
UMLS 2011AA Property
C1704243
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C25157
UMLS 2011AA Property-3
C0005902
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
BSA (In m2;)
Description

PersonBodySurfaceAreaValue

Data type

float

Measurement units
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
m2
Does patient have histologic verification of the malignancy at the indicated time point (Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - Patients with relapsed or refractory solid tumors, CNS tumors or anaplastic large cell lymphoma excluding patients with primary cutaneous ALCL. - - Please note: The requirement for histologic verification does not apply to patients with diffuse intrinsic brain stem tumors, optic pathway tumors, or patients with pineal region tumors with elevations of serum or CSF tumor markers e.g., alpha-fetoprotein or beta-HCG.)
Description

DiseaseHistologicDiagnosisInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Does patient have neuroblastoma
Description

NeuroblastomaDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ObjectClass
C3270
UMLS 2011AA ObjectClass
C0027819
Does patient have ALCL (anaplastic large cell lymphoma)
Description

AnaplasticLargeCellLymphomaDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3720
UMLS 2011AA ObjectClass
C0206180
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Does patient have histologic verification of the malignancy at the indicated time point (For patients with ALK fusion proteins, ALK mutations or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - Indicated time point refers to original diagnosis or relapse. - - Patients must have had histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have confirmed ALK protein, mutations and/or amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. Testing for eligibility purposes must be performed as a CLIA certified assay.)
Description

PersonALKGeneAbnormalityClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C38184
UMLS 2011AA Property-3
C1332080
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did patient have ALK molecular abnormality verified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (For patients with ALK fusion proteins, ALK mutations, or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - To be eligible, patients must have confirmed ALK protein, mutation and/or amplification. Testing for eligibility purposes must be performed as a CLIA certified assay. )
Description

PersonALKGeneAbnormalityVerificationClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C45513
UMLS 2011AA Property-3
C1711411
NCI Thesaurus Property-4
C38184
UMLS 2011AA Property-4
C1332080
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does patient have histologic verification of the malignancy at the indicated time point (For Part A3 patients - - Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of Part suspension or lack of available slots. These patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling.)
Description

PersonRelapseRefractoryNeuroblastomaClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38014
UMLS 2011AA Property
C0205269
NCI Thesaurus Property-2
C3270
UMLS 2011AA Property-2
C0027819
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Metathesaurus Property
C0699753
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does patient meet the disease status requirement
Description

(To be eligible, patient must have either measurable and/or evaluable disease. - - Note: See Protocol Sections 12.2 and 12.3 and 12.6 for definitions.)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25626
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C8507
NCI Thesaurus Property-4
C16112
NCI Thesaurus ValueDomain
C25180
UMLS CUI [1]
C1513041
Is patient's current disease state one for which there is no known curative therapy available or therapy proven to prolong survival with an acceptable quality of life (To be eligible, patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.)
Description

PersonNoStandardTreatmentRegimenOptionsClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C15697
UMLS 2011AA Property-2
C0040808
NCI Thesaurus Property-3
C44275
UMLS 2011AA Property-3
C1442989
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus Property-5
C25374
UMLS 2011AA Property-5
C1518601
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Karnofsky Performance Status Score (To be eligible, patients greater than 16 years of age must have a Karnofsky performance score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I)
Description

KarnofskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Lansky Performance Status Score (To be eligible, patients less than or equal to 16 years of age must have a Lansky play score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I - )
Description

LanskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study (- Myelosuppressive chemotherapy: Solid Tumors: Patients with solid tumors must not have received within 3 weeks of enrollment onto this study 6 weeks if prior nitrosourea. - Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse. For patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy. Note: Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of PF-02341066. - - - Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. - - - Biologic anti-neoplastic agent: At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair. - - - Monoclonal antibodies: At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody. - - - XRT: >= 2 wks for local palliative XRT small port; >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 6 months must have elapsed if prior TBI, craniospinal XRT or >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial BM radiation. - - - Bone Marrow/Stem Cell Transplant or Rescue without TBI: - - Part A1 or Part C: No evidence of active graft vs. host disease and >= 3 months must have elapsed since stem cell transplant or infusion. - - Part A2, Part A3, or Part B: No evidence of active graft vs. host disease and >= 6 weeks must have elapsed since stem cell transplant or infusion. - - )
Description

PersonRecoveredorResolvedPriorTreatmentRegimenClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C49498
UMLS 2011AA Property-2
C1709863
NCI Thesaurus Property-3
C15697
UMLS 2011AA Property-3
C0040808
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior therapy type
Description

PriorTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Did patient receive nitrosourea (If prior therapy was myelosuppressive chemotherapy - - To be eligible, patients with solid tumors must not have received within 6 weeks of enrollment onto this study if prior nitrosourea.)
Description

PersonPriorTreatmentRegimenNitrosoureaCompoundClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C15697
UMLS 2011AA Property-2
C0040808
NCI Thesaurus Property-3
C699
UMLS 2011AA Property-3
C0028210
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Last Treatment Date (prior to enrolling on this study)
Description

LastTreatmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Has patient previously received any of the indicated agents (To be eligible, patients must not have received prior therapy with PF-02341066.)
Description

PersonPriorClinicalStudyAgentClinicalTrialEligibilityCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Organ Function - Hematological
Description

Organ Function - Hematological

Does patient have bone marrow involvement
Description

BoneMarrowInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Does patient have adequate bone marrow function?
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
Lab, Hematology, Sample Collection Date
Description

HematologySpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
WBC
Description

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Absolute neutrophil count (ANC)
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C63321
UMLS 2011AA Property-2
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Segs
Description

LaboratoryProcedureSegmentedNeutrophilOutcomePercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C36719
UMLS 2011AA Property-2
C0229640
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Bands
Description

LaboratoryProcedureNeutrophilBandFormCountResultPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C64830
UMLS 2011AA Property-2
C1882076
NCI Thesaurus ValueDomain
C49100
UMLS 2011AA ValueDomain
C1704610
%
Peripheral Platelet Count
Description

LaboratoryProcedurePlateletResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12520
UMLS 2011AA Property-2
C0005821
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Hemoglobin
Description

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Were transfusions given
Description

TransfusionReceivedInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15408
Organ Function - Non Hematological
Description

Organ Function - Non Hematological

Does patient have adequate renal function?
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
Date of Creatinine Clearance
Description

Creatinine Clearance Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0373595
Creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201976
mg/dL
What is the GFR for the indicated period (ml/min/1.73m2)
Description

LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

Data type

float

Measurement units
  • mL/Min/1.73m2
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C90505
mL/Min/1.73m2
Does patient have adequate liver function?
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
Date
Description

LaboratoryProcedureBilirubinOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Total Bilirubin
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
UMLS CUI [1]
C0201913
mg/dL
Total bilirubin ULN
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
NCI Thesaurus ValueDomain-3
C25706
UMLS 2011AA ValueDomain-3
C1519815
mg/dL
SGPT
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Albumin (Serum)
Description

LaboratoryProcedureAlbuminResultSpecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C214
UMLS 2011AA Property-2
C0001924
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Is patient able to swallow capsules or a liquid suspension
Description

PatientSwallowingAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38028
UMLS 2011AA Property-2
C0011167
Exclusion Criteria
Description

Exclusion Criteria

Pregnancy test done
Description

PregnancyTestPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
Is patient pregnant
Description

PatientPregnancyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Is patient nursing
Description

NursingMotherInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25189
UMLS 2011AA Property
C0026591
NCI Thesaurus ObjectClass
C16926
UMLS 2011AA ObjectClass
C0028677
Has patient agreed to use an effective contraceptive method
Description

ContraceptionAgreementInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Is the patient receiving corticosteroids?
Description

CorticosteroidAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Has patient been on a stable or decreasing dose of corticosteroids for the indicated period
Description

CorticosteroidStableLowerDoseAdministeredIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property
C30103
UMLS 2011AA Property
C0205360
NCI Thesaurus Property-2
C25488
UMLS 2011AA Property-2
C0178602
NCI Thesaurus Property-3
C86568
UMLS 2011AA Property-3
C2003888
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is patient currently receiving any other anticancer or experimental drug therapy
Description

CancerTreatmentConcurrentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus ObjectClass
C16212
UMLS 2011AA ObjectClass
C0920425
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Does patient 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
Is patient, in the opinion of the investigator, able to comply with the safety monitoring requirements of the study
Description

PatientClinicalTrialSafetyComplianceInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C71104
UMLS 2011AA Property
C0008976
NCI Thesaurus Property-2
C25194
NCI Thesaurus Property-3
C60828
UMLS 2011AA Property-2
C0036043
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is patient receiving CYP3A4 substrates with narrow therapeutic indices
Description

PersonCytochromeP4503A4SubstrateDomainEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C17573
UMLS 2011AA Property-2
C1142644
NCI Thesaurus Property-3
C14073
UMLS 2011AA Property-3
C1515032
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did patient receive CYP3A4 inhibitor during the indicated period
Description

PersonCytochromeP4503A4InhibitionAgentEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C17573
UMLS 2011AA Property-3
C1142644
NCI Thesaurus Property-4
C42791
UMLS 2011AA Property-4
C0021469
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did patient receive CYP3A4 inducer during the indicated period
Description

PersonCytochromeP4503A4InductionAgentEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C61367
UMLS 2011AA Property
C0205263
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C17573
UMLS 2011AA Property-4
C1142644
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Consent For Research Studies
Description

Consent For Research Studies

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Was consent signed for Pharmacokinetics
Description

PatientPharmacokineticStudyConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C49663
UMLS 2011AA Property-2
C0201734
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
Description

SpecimenRelatedGeneticResearchConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C17938
UMLS 2011AA Property-2
C0314603
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient consents to tissue submission
Description

PatientCorrelativeStudyTissueSpecimenConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C16100
UMLS 2011AA Property-4
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient consents to blood submission
Description

PatientCorrelativeStudyBloodSpecimenConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C16100
UMLS 2011AA Property-4
C1511524
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Signature
Description

ResponsiblePersonSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
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1 forms
  1. StudyEvent: COG ADVL0912 OPEN Registration Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Stratification
Item
ADVL0912 Stratum
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16153 (NCI Thesaurus Property)
C1514984 (UMLS 2011AA Property)
CL.1
Code List
ADVL0912 Stratum
CL Item
Patients With Relapsed/refractory Solid Tumors (including Cns Tumors), And Anaplastic Large Cell Lymphoma (alcl) Without Bone Marrow Involvement (Patients with relapsed/refractory solid tumors (including CNS tumors), and anaplastic large cell lymphoma (ALCL) WITHOUT bone marrow involvement)
CL Item
Patients With Relapsed/refractory Solid Tumors (including Cns Tumors), And Anaplastic Large Cell Lymphoma (alcl) With Or Without Bone Marrow Involvement (Patients with relapsed/refractory solid tumors (including CNS tumors), and anaplastic large cell lymphoma (ALCL) WITH OR WITHOUT bone marrow involvement)
CL Item
Patients With Relapsed Or Refractory Neuroblastoma, With Or Without Bone Marrow Involvement, Who Are Not Eligible For Part A1 Or A2 Or Cannot Enroll On Part A1 Because Of Stratum Suspension Or Lack Of Available Slots (Patients with relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of stratum suspension or lack of available slots)
TreatmentBeginDate
Item
Treatment Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Item Group
Patient Criteria
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
Were tests to determine eligibility performed during the indicated period (Indicated period refers to prior to enrollment. - - Note: All studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Please see section 4.0 of the protocol for instructions on required repeated eligibility studies if more than 7 calendar days elapse between labs and start of therapy. - )
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAgeEligibilityDeterminationInd-2
Item
Was the patient in the indicated age range at time of study enrollment (To be eligible, patient must be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
PersonGreaterBodySurfaceAreaClinicalTrialEligibilityCriteriaInd-2
Item
Does patient have a BSA (body surface area) greater than or equal to the indicated value (BSA Dose Level 0 and 1 only: To be eligible, patients must have a BSA >= 0.4 at the time of study enrollment. - )
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61421 (NCI Thesaurus Property)
C1704243 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25157 (NCI Thesaurus Property-3)
C0005902 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonBodySurfaceAreaValue
Item
BSA (In m2;)
float
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
DiseaseHistologicDiagnosisInd
Item
Does patient have histologic verification of the malignancy at the indicated time point (Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - Patients with relapsed or refractory solid tumors, CNS tumors or anaplastic large cell lymphoma excluding patients with primary cutaneous ALCL. - - Please note: The requirement for histologic verification does not apply to patients with diffuse intrinsic brain stem tumors, optic pathway tumors, or patients with pineal region tumors with elevations of serum or CSF tumor markers e.g., alpha-fetoprotein or beta-HCG.)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NeuroblastomaDiagnosisInd-2
Item
Does patient have neuroblastoma
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C3270 (NCI Thesaurus ObjectClass)
C0027819 (UMLS 2011AA ObjectClass)
AnaplasticLargeCellLymphomaDiagnosisInd-2
Item
Does patient have ALCL (anaplastic large cell lymphoma)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3720 (NCI Thesaurus ObjectClass)
C0206180 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PersonALKGeneAbnormalityClinicalTrialEligibilityCriteriaInd-2
Item
Does patient have histologic verification of the malignancy at the indicated time point (For patients with ALK fusion proteins, ALK mutations or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - Indicated time point refers to original diagnosis or relapse. - - Patients must have had histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have confirmed ALK protein, mutations and/or amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. Testing for eligibility purposes must be performed as a CLIA certified assay.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C38184 (NCI Thesaurus Property-3)
C1332080 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonALKGeneAbnormalityVerificationClinicalTrialEligibilityCriteriaInd-2
Item
Did patient have ALK molecular abnormality verified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (For patients with ALK fusion proteins, ALK mutations, or ALK amplification defined as greater than 4-fold increase in the ALK signal number as compared to reference signal number on chromosome 2q arm. - - To be eligible, patients must have confirmed ALK protein, mutation and/or amplification. Testing for eligibility purposes must be performed as a CLIA certified assay. )
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C45513 (NCI Thesaurus Property-3)
C1711411 (UMLS 2011AA Property-3)
C38184 (NCI Thesaurus Property-4)
C1332080 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonRelapseRefractoryNeuroblastomaClinicalTrialEligibilityCriteriaInd-2
Item
Does patient have histologic verification of the malignancy at the indicated time point (For Part A3 patients - - Indicated time point refers to original diagnosis or relapse. - - To be eligible, patient must have histologic verification of malignancy at original diagnosis or relapse. - - To be eligible, patients must have relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of Part suspension or lack of available slots. These patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38014 (NCI Thesaurus Property)
C0205269 (UMLS 2011AA Property)
C3270 (NCI Thesaurus Property-2)
C0027819 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C0699753 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Measurable disease
Item
Does patient meet the disease status requirement
boolean
C25190 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C8507 (NCI Thesaurus Property-3)
C16112 (NCI Thesaurus Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI [1])
PersonNoStandardTreatmentRegimenOptionsClinicalTrialEligibilityCriteriaInd-2
Item
Is patient's current disease state one for which there is no known curative therapy available or therapy proven to prolong survival with an acceptable quality of life (To be eligible, patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C44275 (NCI Thesaurus Property-3)
C1442989 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25374 (NCI Thesaurus Property-5)
C1518601 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Karnofsky Performance Status Score (To be eligible, patients greater than 16 years of age must have a Karnofsky performance score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I)
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.13
Code List
Karnofsky Performance Status Score (To be eligible, patients greater than 16 years of age must have a Karnofsky performance score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I)
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 His/her 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 Indicated. Death Not Imminent (30)
CL Item
Very Sick, Hospitalization Indicated. Death Not Imminent (20)
CL Item
Moribund, Fatal Processes Progressing Rapidly (10)
CL Item
Dead (0)
Item
Lansky Performance Status Score (To be eligible, patients less than or equal to 16 years of age must have a Lansky play score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I - )
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.14
Code List
Lansky Performance Status Score (To be eligible, patients less than or equal to 16 years of age must have a Lansky play score greater than or equal to 50. - - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I - )
CL Item
Fully Active, Normal (100)
CL Item
Minor Restrictions In Physically Strenuous Activity (90)
CL Item
Active, But Tires More Quickly (80)
CL Item
Both Greater Restriction Of And Less Time Spent In Play Activity (70)
CL Item
Up And Around, But Minimal Active Play; Keeps Busy With Quieter Activities. (60)
CL Item
Gets Dressed, But Lies Around Much Of The Day; No Active Play, Able To Participate In All Quiet Play And Activities. (50)
CL Item
Mostly In Bed; Participates In Quiet Activities. (40)
CL Item
In Bed; Needs Assistance Even For Quiet Play. (30)
CL Item
Often Sleeping; Play Entirely Limited To Very Passive Activities. (20)
CL Item
No Play; Does Not Get Out Of Bed. (10)
CL Item
Unresponsive (0)
PersonRecoveredorResolvedPriorTreatmentRegimenClinicalTrialEligibilityCriteriaInd-2
Item
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study (- Myelosuppressive chemotherapy: Solid Tumors: Patients with solid tumors must not have received within 3 weeks of enrollment onto this study 6 weeks if prior nitrosourea. - Lymphoma: Patients with lymphoma who relapse during standard maintenance therapy are eligible at time of relapse. For patients with ALCL who relapse while they are receiving cytotoxic therapy, at least 14 days must have elapsed since the completion of cytotoxic therapy. Note: Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of PF-02341066. - - - Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. - - - Biologic anti-neoplastic agent: At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair. - - - Monoclonal antibodies: At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody. - - - XRT: >= 2 wks for local palliative XRT small port; >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 6 months must have elapsed if prior TBI, craniospinal XRT or >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial BM radiation. - - - Bone Marrow/Stem Cell Transplant or Rescue without TBI: - - Part A1 or Part C: No evidence of active graft vs. host disease and >= 3 months must have elapsed since stem cell transplant or infusion. - - Part A2, Part A3, or Part B: No evidence of active graft vs. host disease and >= 6 weeks must have elapsed since stem cell transplant or infusion. - - )
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C49498 (NCI Thesaurus Property-2)
C1709863 (UMLS 2011AA Property-2)
C15697 (NCI Thesaurus Property-3)
C0040808 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Prior therapy type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.16
Code List
Prior therapy type
CL Item
Chemotherapy Myelosuppressive Therapy (Myelosuppressive Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
C15690 (NCI Thesaurus-3)
C1513793 (UMLS 2011AA-4)
CL Item
Hematopoietic Growth Factor (Hematopoietic Growth Factor)
C20427 (NCI Thesaurus)
C0021757 (UMLS 2011AA)
CL Item
Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)
CL Item
Autologous Stem Cell Rescue Stem Cell Transplantation (Stem Cell Transplant or Rescue without TBI)
C15431 (NCI Thesaurus)
C0472699 (UMLS 2011AA)
C82054 (NCI Thesaurus-3)
C2825926 (UMLS 2011AA-4)
CL Item
Prior Therapy (nos) (Prior therapy NOS)
CL Item
No Previous Exposure To Drug (nos) (No prior therapy)
PersonPriorTreatmentRegimenNitrosoureaCompoundClinicalTrialEligibilityCriteriaInd-2
Item
Did patient receive nitrosourea (If prior therapy was myelosuppressive chemotherapy - - To be eligible, patients with solid tumors must not have received within 6 weeks of enrollment onto this study if prior nitrosourea.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C699 (NCI Thesaurus Property-3)
C0028210 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LastTreatmentDate
Item
Last Treatment Date (prior to enrolling on this study)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
PersonPriorClinicalStudyAgentClinicalTrialEligibilityCriteriaInd-2
Item
Has patient previously received any of the indicated agents (To be eligible, patients must not have received prior therapy with PF-02341066.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Organ Function - Hematological
BoneMarrowInvolvementInd-3
Item
Does patient have bone marrow involvement
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does patient have adequate bone marrow function?
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)
HematologySpecimenCollectedDate
Item
Lab, Hematology, Sample Collection Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
LaboratoryProcedureLeukocyteResultUnspecifiedValue
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
Absolute neutrophil count (ANC)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSegmentedNeutrophilOutcomePercentageValue
Item
Segs
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C36719 (NCI Thesaurus Property-2)
C0229640 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureNeutrophilBandFormCountResultPercentageValue
Item
Bands
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64830 (NCI Thesaurus Property-2)
C1882076 (UMLS 2011AA Property-2)
C49100 (NCI Thesaurus ValueDomain)
C1704610 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Were transfusions given
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)
CL.21
Code List
Were transfusions given
CL Item
No Transfusion (No)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Transfusion With Platelets And Red Blood Cells (Yes, both)
CL Item
Transfusion With Platelets (Yes, platelets)
CL Item
Transfusion With Red Blood Cells (Yes, red blood cells)
Item Group
Organ Function - Non Hematological
PatientRenalFunctionRequiredInd-2
Item
Does patient have adequate renal function?
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)
Creatinine Clearance Date
Item
Date of Creatinine Clearance
date
C25164 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201976 (UMLS CUI [1])
LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue
Item
What is the GFR for the indicated period (ml/min/1.73m2)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C90505 (NCI Thesaurus Property-2)
PatientLiverFunctionRequiredInd-2
Item
Does patient have adequate liver function?
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)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Bilirubin, total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1])
LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C1519815 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
Item
SGPT
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAlbuminResultSpecifiedValue
Item
Albumin (Serum)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
PatientSwallowingAssessmentInd-2
Item
Is patient able to swallow capsules or a liquid suspension
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
Item Group
Exclusion Criteria
PregnancyTestPerformedInd-2
Item
Pregnancy test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
PatientPregnancyInd-2
Item
Is patient pregnant
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
NursingMotherInd-3
Item
Is patient nursing
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25189 (NCI Thesaurus Property)
C0026591 (UMLS 2011AA Property)
C16926 (NCI Thesaurus ObjectClass)
C0028677 (UMLS 2011AA ObjectClass)
Item
Has patient agreed to use an effective contraceptive method
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.28
Code List
Has patient agreed to use an effective contraceptive method
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a, Patient Is Not Of Reproductive Potential (N/A, patient is not of reproductive potential)
CorticosteroidAdministrationInd-3
Item
Is the patient receiving corticosteroids?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CorticosteroidStableLowerDoseAdministeredIndicator
Item
Has patient been on a stable or decreasing dose of corticosteroids for the indicated period
boolean
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus Property)
C0205360 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C86568 (NCI Thesaurus Property-3)
C2003888 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CancerTreatmentConcurrentAdministeredInd-2
Item
Is patient currently receiving any other anticancer or experimental drug therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C16212 (NCI Thesaurus ObjectClass)
C0920425 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
PatientInfectionInd-2
Item
Does patient 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)
PatientClinicalTrialSafetyComplianceInd-2
Item
Is patient, in the opinion of the investigator, able to comply with the safety monitoring requirements of the study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C25194 (NCI Thesaurus Property-2)
C60828 (NCI Thesaurus Property-3)
C0036043 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4SubstrateDomainEligibilityDeterminationInd-2
Item
Is patient receiving CYP3A4 substrates with narrow therapeutic indices
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C17573 (NCI Thesaurus Property-2)
C1142644 (UMLS 2011AA Property-2)
C14073 (NCI Thesaurus Property-3)
C1515032 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4InhibitionAgentEligibilityDeterminationInd-2
Item
Did patient receive CYP3A4 inhibitor during the indicated period
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17573 (NCI Thesaurus Property-3)
C1142644 (UMLS 2011AA Property-3)
C42791 (NCI Thesaurus Property-4)
C0021469 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonCytochromeP4503A4InductionAgentEligibilityDeterminationInd-2
Item
Did patient receive CYP3A4 inducer during the indicated period
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C61367 (NCI Thesaurus Property)
C0205263 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C17573 (NCI Thesaurus Property-4)
C1142644 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Consent For Research Studies
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientPharmacokineticStudyConsentInd-2
Item
Was consent signed for Pharmacokinetics
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C49663 (NCI Thesaurus Property-2)
C0201734 (UMLS 2011AA Property-2)
SpecimenRelatedGeneticResearchConsentInd-2
Item
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
boolean
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property-3)
C0314603 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudyTissueSpecimenConsentInd-2
Item
Patient consents to tissue submission
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorrelativeStudyBloodSpecimenConsentInd-2
Item
Patient consents to blood submission
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
ResponsiblePersonSignatureText
Item
Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
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