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N0874 Registration (Step 2) Eligibility Checklist NCT00731731 Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E51877D-925A-72BF-E040-BB89AD436E3B

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E51877D-925A-72BF-E040-BB89AD436E3B

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  1. 8/26/12
  2. 1/9/15
  3. 1/9/15
  4. 7/3/15
  5. 8/5/15
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August 5, 2015

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Creative Commons BY-NC 3.0 Legacy
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Registration Glioblastoma Multiforme N0874 NCT00731731

Phase I: To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

Header
Patient Demographics / Pre-treatment Characteristics
Gender
Method of Payment (check oneUSA only)
Race
Ethnicity
Pre-treatment Requirements
18 Years and older
years
Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review
Bidimensionally measurable or evaluable disease by gadolinium MRI or contrast CT scan
Must begin partial brain radiotherapy on the same day that vorinostat and temozolomide begin. NOTE: Radiotherapy guidelines are detailed in Section 7.1.
Karnofsky performance status of >=60 (Appendix II) or ECOG performance status 0, 1, or 2 (Appendix V). The same scoring system should be used throughout the study
Which scoring system will be used throughout the study
Karnofsky Performance Status
Performance Status
The following laboratory values obtained <= 14 days prior to registration
ANC >= 1500/mL
1000/ul
PLT >= 100,000/mL
1000/uL
WBC >= 3,000/mL
/ul
HgB >=10.0 g/dL (Note: This level may be reached by transfusion)
g/dL
Total bilirubin <= 2.0 x ULN
mg/dL
mg/dL
SGOT (AST) <= 2.0 X ULN
U/L
U/L
Creatinine <= 1.5 mg/dL
mg/dL
Life expectancy >=12 weeks
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
Phase II patient only: Willing and able to complete neurocognitive (see Section 4.2).
Ability to provide informed written consent
Willingness to return to NCCTG or ABTC enrolling institution for follow-up
Phase II patients: Willing to provide mandatory tissue samples (slides or blocks) for research purposes (see Sections 6.1130 and 17.0).
Willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with vorinostat and temozolomide
Exclusion Criteria
Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for 12 weeks after treatment has ended (Note: Vorinostat is an investigational agent whose genotoxic effects on the developing fetus and newborn are unknown.)
Prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors
Prior cranial RT
Prior Gliadel wafers
Known hypersensitivity to any of the components of vorinostat or other agents used in the study
Valproic acid, another histone deacetylase inhibitor, <=2 weeks prior to registration and during treatment.
Other active malignancy <=3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
Uncontrolled infection
Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and adverse events of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure(CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
Inability to take oral medications
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Congenital long QT syndrome
Prolonged QTc interval (>450 msec)
Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes <=7 days prior to registration: Quinidine, procainamide, disopyramide; Amiodarone, sotalol, ibutilide, dofetilide; Erythromycin, clarithromycin; Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Registration Check
Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG or ABTC member physician
Treatment cannot begin prior to registration and must begin <=15 days after registration
Pretreatment tests/procedures must be completed <= 21 days prior to registration
All required baseline symptoms must be documented and graded
Study drug availability checked
Phase II patients: A mandatory translational research component for tissue (slides or blocks) is part of this study; the patient will be automatically registered onto this component (Sections 3.29d and 17.4).
Grouping Factor
Phase
Subgroup Code
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration, the following will be recorded:)
Patient has given NCCTG permission to give tissue sample(s) to outside researchers
Someone may contact me in the future to ask me to allow other uses of my specimens.
Patient has given permission to keep tissue sample(s) for use in genetic research
Is this an NCCTG institution
Patient has agreed to be enrolled on N0392
Patient has agreed to be enrolled on 94-72-52