ID

710

Beschrijving

AMC-061 Enrollment Form (ENR) Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Trefwoorden

Hirntumoren

D016430

Registration

Central Nervous System Neoplasms

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26 augustus 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Brain and Central Nervous System Tumors NCT00890747 Registration - AMC-061 Enrollment Form (ENR) - 2913694v1.0

model
Details

No Instruction available.

1 Formulieren

StudyEvent: AMC-061 Enrollment Form (ENR)
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

Item Group

Unnamed1

TreatmentProjectedBeginDate

Item

Projected Start Date of Treatment (mm/dd/yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

Inclusion Criteria

Item Group

Inclusion/exclusion Criteria

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria061Type

Item

Inclusion Criteria

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.1

Code List

Inclusion Criteria

CL Item

Date Informed Consent Obtained (Date informed consent obtained)

CL Item

Does The Participant Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)

CL Item

Does The Participant Have A Cd4 Count > 50 Cells/ul (Does the participant have a CD4 count > 50 cells/uL)

CL Item

Does The Participant Have The Following Laboratory Parameters Within 7 Days Prior To Study Entry Hemoglobin >= 8.0 Gm/dl Absolute Neutrophil Count (anc) >= 1500 Cells/mm^3 Platelet Count >= 100,000 /mm^3 (Does the participant have the following laboratory parameters within 7 days prior to study entry Hemoglobin >= 8.0 gm/dL Absolute neutrophil count (ANC) >= 1500 cells/mm^3 Platelet count >= 100,000 /mm^3)

CL Item

Creatinine Within Institutional Normal Limits Or Glomerular Filtration Rate (gfr) > 60 Ml/min/m^2 (calculated By The Cockcroft-gault Equation) (Creatinine within institutional normal limits or Glomerular filtration rate (GFR) > 60 mL/min/m^2 (calculated by the Cockcroft-Gault equation))

CL Item

Total Bilirubin <= 1.5 Times Uln (upper Limit Of Normal) (if "no") Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Therapy (if "yes") Is Total Bilirubin < 3.5 Mg/dl And Is Direct Bilirubin <= 1.5 Times Uln (Total bilirubin <= 1.5 times ULN (upper limit of normal) (If "No") Is the elevated bilirubin felt to be secondary to Indinavir therapy (If "Yes") Is total bilirubin < 3.5 mg/dL and is direct bilirubin <= 1.5 times ULN)

CL Item

(if "no) Is The Elevated Bilirubin Felt To Be Secondary To Atazanavir Therapy (if "yes") Is Direct Bilirubin <= 1.5 Times Uln Ast (sgot) And Alt (sgpt) <= 2.5 Times The Uln ((If "No) Is the elevated bilirubin felt to be secondary to Atazanavir therapy (If "Yes") Is direct bilirubin <= 1.5 times ULN AST (SGOT) and ALT (SGPT) <= 2.5 times the ULN)

CL Item

Does The Participant Have A Histologically Or Cytologically Confirmed Nhl, Biopsy-proven Ks Or Solid Tumor Or Hematological Malignancy (Does the participant have a histologically or cytologically confirmed NHL, biopsy-proven KS or solid tumor or hematological malignancy)

CL Item

Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test)

CL Item

Does The Participant Have The Ability And Willingness To Give Written Informed Consent (Does the participant have the ability and willingness to give written informed consent)

CL Item

If The Participant Is Female, And Of Child-bearing Potential, Has She Had A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, and of child-bearing potential, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing)

CL Item

If Yes, Indicate Cancer Type (see Protocol Section 4.0 For Specific Eligibility Criteria) Nhl, Ks, Renal Cell Cancer, Solid Tumor, Hematologic Malignancy (If Yes, indicate cancer type (see protocol section 4.0 for specific eligibility criteria) NHL, KS, Renal Cell Cancer, Solid tumor, Hematologic malignancy)

CL Item

Is The Participant On Stable Anti-retroviral Therapy For At Least 4 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks After Starting Study Drug (Is the participant on stable anti-retroviral therapy for at least 4 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug)

CL Item

If Yes, Indicate Haart Regimen Type Nnrti-based Only, Non Ritonavir Pi-based Only, Ritonavir Pi-based Only, Nnrti- And Non Ritonavir Pi-based, Nnrti- And Ritonavir Pi-based, Neither Pi Nor Nnrti Based (If Yes, indicate HAART regimen type NNRTI-based only, Non ritonavir PI-based only, Ritonavir PI-based only, NNRTI- and non ritonavir PI-based, NNRTI- and ritonavir PI-based, Neither PI nor NNRTI based)

CL Item

Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)

CL Item

Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)

CL Item

Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))

CL Item

Participant's Age (in Years) (Participant's age (in years))

Exclusion Criteria

Item Group

Exclusion Criteria

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria061Type

Item

Exclusion Criteria

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

Exclusion Criteria

CL Item

Does The Participant Have A Concurrent Active Opportunistic Infection (Does the participant have a concurrent active opportunistic infection)

CL Item

Does The Participant Have A History Of Serious Ventricular Arrhythmia (ventricular Tachycardia (vt) Or Ventricular Fibrillation (vf) >= 3 Beats In A Row) (Does the participant have a history of serious ventricular arrhythmia (ventricular tachycardia (VT) or ventricular fibrillation (VF) >= 3 beats in a row))

CL Item

Does The Participant Have Ongoing Ventricular Cardiac Dysrhythmias Of Nci Ctcae Grade >= 2 (Does the participant have ongoing ventricular cardiac dysrhythmias of NCI CTCAE grade >= 2)

CL Item

Does The Participant Have Clinically Significant Cardiovascular Disease, Including Uncontrolled Hypertension (diastolic Blood Pressure >=100 Mmhg Despite Optimal Medical Therapy) Or Unstable Angina (Does the participant have clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure >=100 mmHg despite optimal medical therapy) or unstable angina)

CL Item

Does The Participant Have A Pre-existing Thyroid Abnormality That Cannot Be Maintained With Medication To Keep Measures Of Thyroid Stimulating Hormone Within The Normal Range (Does the participant have a pre-existing thyroid abnormality that cannot be maintained with medication to keep measures of thyroid stimulating hormone within the normal range)

CL Item

Does The Participant Have A Psychiatric Illness That Would Limit Compliance With Study Requirements (Does the participant have a psychiatric illness that would limit compliance with study requirements)

CL Item

Does The Participant Have A Qtc Interval > 500 Msec (Does the participant have a QTc interval > 500 msec)

CL Item

Does The Participant Have Another Severe And/or Life-threatening Medical Disease (Does the participant have another severe and/or life-threatening medical disease)

CL Item

Does The Participant Have Gastrointestinal Tract Disease Resulting In An Inability To Take Oral Medication Or A Requirement For Iv Alimentation, Prior Surgical Procedures Affecting Absorption, Or Active Peptic Ulcer Disease (Does the participant have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)

CL Item

Does The Participant Have Serious Cardiac Arrhythmia Requiring Medication (Does the participant have serious cardiac arrhythmia requiring medication)

CL Item

Has The Participant Had A Myocardial Infarction, Severe/unstable Angina, Coronary Artery Bypass Graft, Cerebrovascular Accident, Transient Ischemic Attack, Or Pulmonary Embolism Within 6 Months Of Study Entry (Has the participant had a myocardial infarction, severe/unstable angina, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry)

CL Item

Does The Participant Have An Abnormal Left Ventricular Ejection Fraction Per Institutional Standards (Does the participant have an abnormal Left Ventricular Ejection Fraction per institutional standards)

CL Item

Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry)

CL Item

Has The Participant Had Major Surgery Or Radiation Within 3 Weeks Prior To Study Entry (Has the participant had major surgery or radiation within 3 weeks prior to study entry)

CL Item

Has The Participant Received Antineoplastic Therapy, Including Investigational Drug Or Standard Treatment, Within 2 Weeks Of Study Entry? (must Be Able To Demonstrate Adequate Recovery From Prior Therapy-related Toxicities.) (Has the participant received antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry? (Must be able to demonstrate adequate recovery from prior therapy-related toxicities.))

CL Item

If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)

CL Item

Will The Participant Undergo Concurrent Treatment With Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, That Are Known To Inhibit Or Induce Cyp3a4 (Will the participant undergo concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4)

Unnamed1

Item Group

Exclusion Criteria

CancerSiteType

Item

Type of Cancer

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)

CL.3

Code List

Type of Cancer

CL Item

Non-hodgkin's Lymphoma (Non-Hodgkin's lymphoma)

C3211 (NCI Thesaurus)
C0024305 (UMLS 2011AA)

CL Item

Kaposi Sarcoma (KS)

C9087 (NCI Thesaurus)
C0036220 (UMLS 2011AA)

CL Item

Renal Cell Carcinoma (Renal Cell Cancer)

C9385 (NCI Thesaurus)
C0007134 (UMLS 2011AA)

CL Item

Solid Neoplasm (Solid tumor)

C9292 (NCI Thesaurus)
C0280100 (UMLS 2011AA)

CL Item

Hematologic Malignancy (Hematologic malignancy)

PatientHighlyActiveAntiretroviralTherapyRegimenType

Item

HAART regimen type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16165 (NCI Thesaurus Property)
C0887947 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.4

Code List

HAART regimen type

CL Item

Nnrti-based Only (NNRTI-based only)

CL Item

Non-ritonavir Pi-based Only (Non-ritonavir PI-based only)

CL Item

Ritonavir Pi-based Only (Ritonavir PI-based only)

CL Item

Nnrti- And Non-ritonavir Pi-based (NNRTI- and non-ritonavir PI-based)

CL Item

Nnrti- And Ritonavir Pi-based (NNRTI- and ritonavir PI-based)

CL Item

Neither Pi Nor Nnrti Based (Neither PI nor NNRTI based)

KarnofskyPerformanceStatusScore

Item

Karnofsky Performance Status (must be > 60%)

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

PatientAgeYearCount

Item

Age (in years)

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

InformedConsentFormSignedDate

Item

Date Informed Consent Signed (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

Consent For Participation in Pharmacogenetics Study and The Use Of Future Tissue Specimens

Item Group

Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens

Item

Does the participant agree to participate in the pharmacogenetics study associated with this protocol

text

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property)
C0314603 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.5

Code List

Does the participant agree to participate in the pharmacogenetics study associated with this protocol

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BloodTissueSpecimenOtherDiseasesandDisordersFutureResearchConsentInd-2

Item

Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Brain and Central Nervous System Tumors NCT00890747 Registration - AMC-061 Enrollment Form (ENR) - 2913694v1.0

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