Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXWritten, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study specific procedure.Xx_NEWLINE_xXWillingness and ability to consent (and assent if under age 18) for self to participate in studyXx_NEWLINE_xXAt least 5 years old at time of consent to remediation interventionXx_NEWLINE_xXPatients with impaired decision making capacity may participate in the study if a legal authorized representative is available to consentXx_NEWLINE_xXThe patient or legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXWillingness and ability to consent to participate in studyXx_NEWLINE_xXPatients with mental deficits or psychiatric conditions that preclude them from giving informed consent or following protocolXx_NEWLINE_xXPatients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-upXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separately; consent and HIPPA authorization must be obtained prior to any screening proceduresXx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirementsXx_NEWLINE_xXWritten informed consent which is consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation.Xx_NEWLINE_xXAny condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocolXx_NEWLINE_xXSubjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up \r\n* Note: informed consent may be obtained prior to start of the specified screening window\r\n* Note: procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocolXx_NEWLINE_xXInformed consent must be obtained according to St. Jude guidelines before enrollment into studyXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.Xx_NEWLINE_xXWritten informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirementsXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consent.Xx_NEWLINE_xXAny HSCT within 6 months prior to signing informed consentXx_NEWLINE_xXDementia or altered mental status that would preclude understanding and rendering of informed consentXx_NEWLINE_xXSubject has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP Guidelines and applicable local regulations.Xx_NEWLINE_xXParticipant must consent to provide the following for biomarker analyses:Xx_NEWLINE_xXVoluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluationsXx_NEWLINE_xXPatients must give informed consent prior to initiation of therapyXx_NEWLINE_xXSubject must have a brain scan performed during Screening or within 3 months prior to signing informed consent;Xx_NEWLINE_xXSubject has any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with proceduresXx_NEWLINE_xXCOHORT 2: Be >= 65 years of age on day of signing informed consentXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXPatient has had surgery within seven days prior to the date of informed consent.Xx_NEWLINE_xXPotential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separately; written informed consent must be obtained from a potential subject prior to the conduct of any study-specific proceduresXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.Xx_NEWLINE_xXAny other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consentXx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXInformed consent/assentXx_NEWLINE_xXSubjects unable to comprehend and give informed consent are excluded.Xx_NEWLINE_xXNeurological or psychiatric disorders which may influence understanding of study and informed consent procedures.Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWilling to agree that the local medical oncologist may be informed that patient has agreed to participate in the studyXx_NEWLINE_xXMale or female ? 18 years of age. 4. Weigh ? 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative ?-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent.Xx_NEWLINE_xXThe patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human ServicesXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting the release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPROCUREMENT: Patient able to give informed consentXx_NEWLINE_xXPatient, parent/guardian able to give informed consentXx_NEWLINE_xXPatients must agree, as part of the informed consent, to provide blood for pharmacokinetics analysisXx_NEWLINE_xXWritten informed consent for screening and trial participation procedures including biological material transfer and handling.Xx_NEWLINE_xXThe subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.Xx_NEWLINE_xXThe subject or subject's medical power of attorney has provided written consent to participate in this study.Xx_NEWLINE_xXMust consent to provide biomarker analyses as described in the protocol.Xx_NEWLINE_xXAble to understand the study procedures and agree to participate in the study by providing written informed consentXx_NEWLINE_xXAbility to give informed consent.Xx_NEWLINE_xXMale or female, ? 18 years old with the ability to understand and provide signed and witnessed informed consent, and agree to comply with protocol requirementsXx_NEWLINE_xXHave mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.Xx_NEWLINE_xXA patient must be capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalfXx_NEWLINE_xXLegal incapacity/limited legal capacity for providing informed consent.Xx_NEWLINE_xXInformed consent cannot be obtained either from the patient or legal representativeXx_NEWLINE_xXDocumented informed consent of participant and/or legally authorized representativeXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXDementia or altered mental status that would preclude understanding and rendering of informed consentXx_NEWLINE_xXProvided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXAny mental or medical condition that prevents the subject from giving informed consent or participating in the trial.Xx_NEWLINE_xXPatients must have the psychological ability and general health that permits informed consent, completion of the study requirements, and required follow upXx_NEWLINE_xXPatient must sign informed consent form to indicate patient's understanding study's purpose and procedures and willingness to participate. Should patient be incapable of giving consent, the patient's legally authorized representative (as defined by local regulation) must give consent. However, should patient, in any manner, choose not to participate this takes precedence and will be respected.Xx_NEWLINE_xXWritten informed consent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelinesXx_NEWLINE_xXWritten, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.Xx_NEWLINE_xXProvision of informed consentXx_NEWLINE_xXParticipant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).Xx_NEWLINE_xXFor inclusion in optional genetic research, the patient must provide a written informed consent for genetic research.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXPatients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocolXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXHave dementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXAbility to understand and willingness to sign a written informed consent that is consistent with International Council for Harmonisation to organize applications to regulatory authorities for registration of pharmaceuticals for human use-good clinical practice (ICH-GCP) guidelinesXx_NEWLINE_xXPatient or parent/guardian capable of providing informed consentXx_NEWLINE_xXPatient or parent/guardian capable of providing informed consentXx_NEWLINE_xXDiagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agreesXx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXPatients, parents/guardian(s), legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriateXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocolXx_NEWLINE_xXELIGIBILITY FOR SCREENING: Informed consent (and assent as applicable) obtained from patient/guardianXx_NEWLINE_xXPatients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely are excludedXx_NEWLINE_xXNo written consent of the patient or his/her parents or legal guardianXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXInformed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted); patients should have the ability to understand and the willingness to sign a written informed consent documentXx_NEWLINE_xXThe patient or the patient’s legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAny medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with proceduresXx_NEWLINE_xXMust be capable of giving consent to participate in the studyXx_NEWLINE_xXSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXCognitively impaired patients who cannot give informed consent and do not have a legal guardianXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXThe patient or their legal guardian must give their informed consentXx_NEWLINE_xXAbility to understand and willing to provide informed consent\r\n* If patient unable to understand informed consent, a previously designated durable power of attorney for healthcare or an individual with legal authority may substitute in this capacity\r\n* Assignment of a durable power of attorney for healthcare if not already doneXx_NEWLINE_xXWilling to give informed consent\r\n* A parent or guardian must be available for giving consent for pediatric subjects under 18 years of ageXx_NEWLINE_xXAbility to understand and the willingness to sign a written informed consent document. Patients with Impaired Decision Making Capacity (IDMC) can have a Legally Authorized Representative sign on their behalf. Documentation, such as a Power of Attorney, must be presented in order for a substitute decision maker to be allowedXx_NEWLINE_xXWilling and able to provide written informed consent (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXDONOR: Able to provide informed consent for the donation process per institutional standards.Xx_NEWLINE_xXWritten informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. Consent for the use of any residual material from biopsy (archival tissue) and serial blood draws will be required for enrollment.Xx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXHave the capacity to give informed consentXx_NEWLINE_xXAny altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent or limit compliance with study requirementsXx_NEWLINE_xXSufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questionsXx_NEWLINE_xXRefuses to give informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the Unites States of America [USA] only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXAbility of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriateXx_NEWLINE_xXHas any mental or medical condition that prevents the patient from giving informed consent or participating in the trialXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXWilling and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXUncontrolled medical, psychological, familial, sociological, or geographical conditions that interfere with the patient’s safety, ability to provide informed consent, or ability to comply with the protocolXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXFor inclusion in the optional PGx research, patients must provide informed consent for the genetic sampling and analyses.Xx_NEWLINE_xXMen and women ?18 years old on the day of signing informed consent.Xx_NEWLINE_xXSigned and dated written informed consent prior to admission to the study in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislationXx_NEWLINE_xXWritten informed consent and authorization for release of personal health information obtained according to local laws.Xx_NEWLINE_xXAfter being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinationsXx_NEWLINE_xXSign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's diseaseXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. This will be assessed by the consenting physician using general questions as outlined in Etchell’s 1999 publication titled Assessment of Patient Capacity to Consent to Treatment. These are general conversation based questions that assess the patient’s ability to understand the medical problem, proposed treatment, alternatives to proposed treatment, and understand the consequences of the medical choicesXx_NEWLINE_xXThe subject (or legally acceptable representative if applicable) provides written informed consent for the trial. The subject may also provide consent for future biomedical research. However the subject may participate in the main trial without participating in future biomedical research.Xx_NEWLINE_xXSigned and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.Xx_NEWLINE_xXAny medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with proceduresXx_NEWLINE_xXPatients with a confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to signing informed consent are ineligibleXx_NEWLINE_xXPsychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study proceduresXx_NEWLINE_xXAbility to understand and willingness to provide written informed consent signed and dated prior to admission to the study in accordance with International Conference on Harmonisation (ICH)-Good Clinical Practices (GCP) guidelines and to the local legislationXx_NEWLINE_xXPatient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study proceduresXx_NEWLINE_xXDocumented informed consent of participant and/or legally authorized representativeXx_NEWLINE_xXWritten informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluationsXx_NEWLINE_xXPatient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.Xx_NEWLINE_xXHave the capacity to give informed consentXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXPatients must be able to understand and be willing to give informed consent; parent or legal representative will be asked to consent for patients younger than 18 years oldXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXHas the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent processXx_NEWLINE_xXPatients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.Xx_NEWLINE_xXHave evidence of radiographic disease progression with scan documenting progression occurring within 8 weeks of signing informed consentXx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtained.Xx_NEWLINE_xXPatients must be capable of understanding and providing a written informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXInformed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information obtainedXx_NEWLINE_xXProvision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this clinical study protocol, so long as they consent to that part.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXSubject is 1 to < 21 years of age at the time of signing the Informed Consent Form/Informed Assent Form (ICF/IAF).Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health informationXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXSubjects must give informed consent according to the rules and regulations of the individual participating sites.Xx_NEWLINE_xXWilling to consent and accept randomizationXx_NEWLINE_xXAny condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient’s ability to sign the informed consent and comply with study proceduresXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXWillingness and ability to consent for self to participate in studyXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health informationXx_NEWLINE_xXEach subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.Xx_NEWLINE_xXWritten informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXMust have reached legal age to consent.Xx_NEWLINE_xXHave provided written consent for protocol directed biopsiesXx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXSigned and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislationXx_NEWLINE_xXPatients or appropriate legally authorized representatives must possess the ability to give informed consentXx_NEWLINE_xXDocumented informed consent of the participant or legally authorized representativeXx_NEWLINE_xXSubject must understand risks and benefits of the protocol and be able to give informed consentXx_NEWLINE_xXWritten informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluationXx_NEWLINE_xXParticipants must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's diseaseXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXWritten, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) guidelinesXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXHistory of psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consentXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocolXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXSubjects must sign a written informed study consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow upXx_NEWLINE_xXSignificant medical psychiatric cognitive or other conditions that may compromise the patient ability to understand the patient information to give informed consent to comply with the study protocol or to complete the studyXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXPatients must be capable of giving informed consent and be willing and able to comply with scheduleXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXPsychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study proceduresXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; provision of informed consent prior to any study procedures\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXSigning of the Informed Consent FormXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.Xx_NEWLINE_xXCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent formXx_NEWLINE_xXAbility to give informed consent and comply with the protocolXx_NEWLINE_xXProvision of genetics research informed consentXx_NEWLINE_xXBe able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures.Xx_NEWLINE_xXAbility to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health informationXx_NEWLINE_xXHas any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent, and/or comply with the study procedures.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the subject/legal representative prior to performing any protocol-related proceduresXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXProvide informed consent for genetic sampling and analysesXx_NEWLINE_xXDocumented informed consent/assent of the participant or legally responsible guardianXx_NEWLINE_xXAll participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the researchXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent for (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXCELL PROCUREMENT: Written informed consent for procurement signed by subject or legal guardian of a pediatric subject and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXLYMPHODEPLETION: Written informed consent for the main study signed by subject or legal guardian of a pediatric subjectXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXIn the judgment of the consenting professional cognitively able to provide informed consentXx_NEWLINE_xXDocumented informed consent of the participant and/or legally authorized representativeXx_NEWLINE_xXDocumented informed consent of the subject and/or legally authorized representativeXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and procedures or unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXThe patient/legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the United States of America [USA]; European Union Data Privacy Directive in the European Union [EU]) before any study-specific procedures, including screening evaluations, sampling, and analysesXx_NEWLINE_xXAbility to understand and the willingness to sign a written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelinesXx_NEWLINE_xXSubject or subject's legally acceptable representative has provided informed consent.Xx_NEWLINE_xXProvision of signed and dated, written Informed Consent Form (ICF) prior to any trial-specific procedures, sampling, or analyses. If a patient declines to participate in the voluntary pharmacogenetics component of the trial, he/she will not be excluded from other aspects of the trial.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWillingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)Xx_NEWLINE_xXBe willing and able to provide written informed consent/assent for the trial; the subject may also provide consent for future biomedical research; however, the subject may participate in the main trial without participating in future biomedical researchXx_NEWLINE_xXAll subjects must have the ability to understand and the willingness to sign a written informed consent that has been approved by the City of Hope Institutional Review Board (COH IRB); the patient, a family member and transplant staff physician (physician, nurse, social worker) will meet at least once prior to the subject signing consent; during this meeting all pertinent information with respect to risks and benefits to donor and recipient will be presented; alternative treatment modalities will be discussed; the risks are explained in detail in the enclosed consent formXx_NEWLINE_xXWritten informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWritten informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witnessXx_NEWLINE_xXMust be capable of providing informed consentXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXWritten informed consent must be obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)Xx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXDiagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agreesXx_NEWLINE_xXDocumented informed consent of the participantXx_NEWLINE_xXAll patients must have provided informed consent for correlative studiesXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of American [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocolXx_NEWLINE_xXSigned written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelinesXx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXAny other co-existing medical or psychological condition(s) that will preclude participation in the study or compromise ability to give informed consent and/or comply with study procedures.Xx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXAble to understand the potential risks, benefits, and requirements of the study and are willing to provide informed consent; an informed consent form for this study that is signed by the patient or his/her legally authorized representative is required prior to enrollmentXx_NEWLINE_xXAble to understand the potential risks, benefits, and requirements of the study and are willing to provide informed consent; an informed consent form for this study that is signed by the patient or his/her legally authorized representative is required prior to enrollmentXx_NEWLINE_xXPatients must give documented informed consent to participate in this studyXx_NEWLINE_xXSubject/parental/guardian permission (informed consent), and child assent for subjects >= 7 yearsXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXPatients or parents/legal guardian must be able to give informed consentXx_NEWLINE_xXmCRPC EXPANSION COHORT: Patient must be capable of understanding and complying with protocol requirements and is willing to give informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXAbility to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witnessXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXThe patient must sign an informed consent form (ICF) indicating that s/he understands the purpose of, and procedures required for, the study and is willing to participateXx_NEWLINE_xXDementia or altered mental status that would prohibit the understanding and giving of informed consentXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Information Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXThe subject must be deemed competent to give informed consentXx_NEWLINE_xXThe subject is cognitively impaired, and unable to give informed consentXx_NEWLINE_xXability to consentXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g.,) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXPRIOR TO CELL PROCUREMENT: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form for procurementXx_NEWLINE_xXPatients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXPatients unable to comprehend and give informed consent are excludedXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXUse of medications or supplements that are known to affect PSA within 30 days prior to informed consent, including toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements; no dutasteride within 90 days prior to informed consentXx_NEWLINE_xXSubject is capable of understanding the informed consent processXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXThe subject has been fully informed about the study and has signed the informed consent form and, where appropriate, Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXSigned informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial informationXx_NEWLINE_xXPatients with dementia/psychiatric illness/social situations limiting compliance with study requirements or understanding and/or giving of informed consent are not eligibleXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXSubject must be able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapyXx_NEWLINE_xXSigned informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial informationXx_NEWLINE_xXPatients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consentXx_NEWLINE_xXPatients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study; written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXPatient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676; parent or guardian of minor patient able to provide written informed consent for the long-term follow-up gene therapy study: 2006-0676Xx_NEWLINE_xXHave dementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration; NOTE: HIPAA authorization may be included in the informed consent or obtained separately; subject must have the ability to understand and willingness to sign the written informed consent documentXx_NEWLINE_xXGroup 2: consent to undergo research biopsiesXx_NEWLINE_xXSign Subject Information Sheet and Informed Consent FormXx_NEWLINE_xXEncephalitis, meningitis, or uncontrolled seizures in the year prior to informed consentXx_NEWLINE_xXPatient, or the patient’s legal representative, has voluntarily agreed to participate by giving written informed consentXx_NEWLINE_xXPatients who are at the time of signing informed consent, a regular user of any illicit drugs, substance abuser or who have a recent history of drug or alcohol abuseXx_NEWLINE_xXPatient understands the procedures and agrees to comply with the study requirements by providing written informed consentXx_NEWLINE_xXPatients must have the ability to give informed consentXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluationsXx_NEWLINE_xXCognitive impairment that precludes a patient from acting as his or her own agent to provide informed consentXx_NEWLINE_xXSubjects unable to give informed consentXx_NEWLINE_xXSubject has provided informed consentXx_NEWLINE_xXAdult donors must be an HLA 4-8/8 match with the patient and must be capable of providing informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatient will be approached for enrolling in the study by the PI, treating physician or a designee; informed consent will be obtained by the PI, co-investigator (co-I) or a qualified designeeXx_NEWLINE_xXPatients who have signed informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXWillingness and ability to consent for self to participate in studyXx_NEWLINE_xXPatient understands the nature of the procedure, is willing to comply with associated follow–up evaluations, and provide written informed consent prior to the procedureXx_NEWLINE_xXWritten informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXSubjects must be willing and able to provide written informed consent for the trial and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of protected health information\r\n* NOTE: HIPPA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXHas any mental or medical condition that prevents the patient from giving informed consentXx_NEWLINE_xXAny perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)Xx_NEWLINE_xXSubject is able to provide written informed consent, comply with protocol visits and procedures, and take oral medication, and does not have any active infection or comorbidity that would interfere with therapy.Xx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessmentsXx_NEWLINE_xXPROCUREMENT: Patient able to give informed consentXx_NEWLINE_xXPatient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participateXx_NEWLINE_xXCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent formXx_NEWLINE_xXAbility to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed Personalized ANtibodies for Gastro-Esophageal Adenocarcinoma (PANGEA) treatment with first, second and third line therapy as toleratedXx_NEWLINE_xXCapable of providing informed consent and complying with trial procedures.Xx_NEWLINE_xXPatient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the studyXx_NEWLINE_xXAll research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signedXx_NEWLINE_xXAll subjects must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signedXx_NEWLINE_xXAll research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signedXx_NEWLINE_xXPatients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entryXx_NEWLINE_xXPatient has voluntarily agreed to participate by giving written informed consent/assent for the trialXx_NEWLINE_xXPatient is, at the time of signing informed consent, a regular user (including illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)Xx_NEWLINE_xXPatients must have the ability to give informed consentXx_NEWLINE_xXSigned informed consent indicating awareness of the scheduling and side effects, as well as testing requirements, of this programXx_NEWLINE_xXParticipant has the ability and the willingness to sign the informed consent document (for adults only, for participants with mild cognitive abilities may use a legally authorized representative)Xx_NEWLINE_xXPatient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen yearsXx_NEWLINE_xXAble and willing to provide written authorization for use and release of health and research study informationXx_NEWLINE_xXPatients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).Xx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).Xx_NEWLINE_xXCapable of providing informed consentXx_NEWLINE_xXAbility to comprehend and willing to sign an informed consent, assent obtained from minorsXx_NEWLINE_xXPatient capable of giving informed consentXx_NEWLINE_xXPatients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entryXx_NEWLINE_xXClinical performance status of ECOG 0-2 within 30 days of signing informed consent (Turnstile II)Xx_NEWLINE_xXHave the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.Xx_NEWLINE_xXPatient capable of giving informed consentXx_NEWLINE_xXHistory of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consentXx_NEWLINE_xXPatient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen yearsXx_NEWLINE_xXAt least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day-after signing research informed consentXx_NEWLINE_xXNewly diagnosed MCL: Age > 65 years at the time of signing the informed consentXx_NEWLINE_xXCapable of informed consentXx_NEWLINE_xXWritten informed consent obtained prior to enrolling in roll-over study and receiving study medication • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witnessXx_NEWLINE_xXLegal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form; note: for inclusion on biology studies after enucleation, the patient or his/her legal guardian, as appropriate, must provide written informed consent for SJRET6 protocol within 60 days of the removal of the tissue (eye) sampleXx_NEWLINE_xXPatient or patient’s guardian is able to give informed consentXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXPatient is, at the time of signing informed consent, a regular user of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuseXx_NEWLINE_xXPatients must be able to give informed consent; parent or legal representative will be asked to consent for patients younger than 18 year oldXx_NEWLINE_xXDONOR: Unable to give informed consentXx_NEWLINE_xXPatients must give documented informed consent to participate in this studyXx_NEWLINE_xXCOHORT 3: ATOPIC DERMATITIS PATIENTS: All subjects and/or their legally authorized representative (LAR) must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent; pediatric patients will be included in age appropriate discussions and age appropriate assent will be obtained in accordance with NIH guidelinesXx_NEWLINE_xXThere will be no upper age limit for eligibility; elderly patients will be eligible for participation provided they are competent to provide informed consent, or written consent can be provided by their duly appointed healthcare proxyXx_NEWLINE_xXAble and willing to give informed consent, and to undergo staging including PET scanningXx_NEWLINE_xXPatients unable to give informed consent for the study will be excludedXx_NEWLINE_xXCapability of providing informed consentXx_NEWLINE_xXWritten Authorization for Use and Release of Health and Research Study Information (Health Insurance Portability and Accountability Act [HIPAA] authorization per institutional requirements)Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health informationXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; Note: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXHave mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and procedures; unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXAll patients must have a surgical and medical oncology consult prior to signing informed consentXx_NEWLINE_xXOvert psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-complianceXx_NEWLINE_xXPatients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entryXx_NEWLINE_xXPhysical or emotional status that would prevent informed consent, protocol compliance, or adequate follow-upXx_NEWLINE_xXPatients, parents/guardian(s), legally authorized representatives (LAR), or durable power of attorney must be able to give consent and sign the informed consent document; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 12 years of age, when appropriateXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXDONOR: Ability to give informed consentXx_NEWLINE_xXPatients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entryXx_NEWLINE_xXMust have the capacity to give informed consentXx_NEWLINE_xXWritten informed consent by patients and/or their parents or legal guardians; assent for those patients inclusive of ages 12 to 17Xx_NEWLINE_xXPatients with psychiatric or addictive disorders that would preclude obtaining informed consentXx_NEWLINE_xXThe donor and the patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policy approved by the United States (U.S.) Department of Health and Human ServicesXx_NEWLINE_xXPatients must be capable of informed consentXx_NEWLINE_xXThe patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on studyXx_NEWLINE_xXRecipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of MinnesotaXx_NEWLINE_xXPsychological condition that renders the patient unable to understand the informed consentXx_NEWLINE_xXPatients must demonstrate the ability and willingness to give informed consent.Xx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXAble to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.Xx_NEWLINE_xXSigned informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedureXx_NEWLINE_xXSubject must be >=18 years of at the time of signing the informed consent.Xx_NEWLINE_xXCapable of giving signed informed consent which includes compliance with the requirements and restrictions specified. Additional Inclusion criteria for Subjects in Part 2:Xx_NEWLINE_xXPsychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consentXx_NEWLINE_xXPatient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.Xx_NEWLINE_xXFollowing receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXProvision of informed consent priorXx_NEWLINE_xXVoluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluationsXx_NEWLINE_xXCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent formXx_NEWLINE_xXPsychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.Xx_NEWLINE_xXPsychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.Xx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.Xx_NEWLINE_xXPatients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.Xx_NEWLINE_xXWritten informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.Xx_NEWLINE_xXSubject is at least 65 years old at the time of signing the consent form.Xx_NEWLINE_xXSigned, written informed consent must be obtained and documented according to ICH-GCP, the local regulatory requirements, and local data protection laws prior to study-specific screening procedures.Xx_NEWLINE_xXWritten informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelinesXx_NEWLINE_xXCapable of providing informed consent and complying with trial procedures.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; note: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXCognitive impairment such as to preclude informed consentXx_NEWLINE_xXCases involving subjects who are minors, pregnant or require an authorized representative for informed consentXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).Xx_NEWLINE_xXWritten informed consent and authorization for release of personal health information obtained according to local laws.Xx_NEWLINE_xXDementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.Xx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entryXx_NEWLINE_xXHas read and understands the informed consent form (ICF) and has given written ICF prior to any study proceduresXx_NEWLINE_xXProvided written authorization for use and release of health and research study information.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXAdults capable of giving informed consent.Xx_NEWLINE_xXDocumented informed consent of the participant and/or the legally authorized representativeXx_NEWLINE_xXEncephalitis, meningitis, or uncontrolled seizures in the year prior to informed consentXx_NEWLINE_xXAbility to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.Xx_NEWLINE_xXSigned informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial informationXx_NEWLINE_xXPresence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding and/or giving of informed consentXx_NEWLINE_xXWritten informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the patient prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXRENAL & BLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the studyXx_NEWLINE_xXBLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the studyXx_NEWLINE_xXPatients who are cognitively impaired and unable to consent for the studyXx_NEWLINE_xXWritten informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXPatient is capable of giving informed consentXx_NEWLINE_xXDocumented informed consent of the participant and/or legally authorized representativeXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and procedures or unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXSigned written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXEach subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICFXx_NEWLINE_xXAdults unable to consentXx_NEWLINE_xXAbility to consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration for protocol therapy\r\n* NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXAbility to give informed consent and comply with the protocolXx_NEWLINE_xXPatients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-upXx_NEWLINE_xXThe subject must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures.Xx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXThe subject must be deemed competent to give informed consentXx_NEWLINE_xXThe subject is unable to give informed consentXx_NEWLINE_xXThe subject is cognitively impaired, and unable to give informed consentXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXDementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXWritten informed consent obtained from study participant or study participant’s legal representative and ability for study participant to comply with the requirements of the studyXx_NEWLINE_xXSubjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures; patients with Impaired Decision Making Capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) may be considered eligible for this study at the treating physician’s discretion, provided that the physician is reasonably sure that the possible risks and benefits of the study are clear and that the patient will take the drug as prescribedXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXWritten informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXInformed consent and assent obtained as appropriateXx_NEWLINE_xXThe patient must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health informationXx_NEWLINE_xXHistory of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian)Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPPA) authorization for release of personal health informationXx_NEWLINE_xXPatient or appointed surrogate decision-maker or legally authorized representative must have ability to understand the purpose and risks of the study and willingness to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXThe participant (or legally acceptable representative if applicable) provides written informed consent for the trialXx_NEWLINE_xXPatient (or his or her legally accepted representative) has provided written informed consent to participate in the studyXx_NEWLINE_xXSigned informed consent to participate in the study, including participation in the expansion cohort after safety of enzalutamide and gemcitabine and cisplatin have been established, must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written informationXx_NEWLINE_xXNot willing to follow protocol requirements or to give informed consentXx_NEWLINE_xXAny history of HIV-1 associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)Xx_NEWLINE_xXProvide voluntary written consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information, approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC)Xx_NEWLINE_xXAny perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)Xx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent authorization permitting release of personal health information prior to study entryXx_NEWLINE_xXBefore any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnelXx_NEWLINE_xXUntreated psychiatric conditions preventing informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAble to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)Xx_NEWLINE_xXUnable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consentXx_NEWLINE_xXDONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)Xx_NEWLINE_xXDONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consentXx_NEWLINE_xXWritten informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXInformed consent and assent (as applicable) obtained from parent/guardian and childXx_NEWLINE_xXParticipants must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow upXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting the release of personal health informationXx_NEWLINE_xXPatients unable to comprehend and give informed consent are excludedXx_NEWLINE_xXAbility to understand and willingness to provide informed consent, and the willingness to comply with the requirements of the protocol; informed consent may be obtained with the assistance of a medical translator according to institutional policiesXx_NEWLINE_xXPatients unable to comprehend and give informed consent are excludedXx_NEWLINE_xXSubject has a psychiatric disorder, altered mental status or social situation that would preclude understanding of the informed consent process and/or limit compliance with study requirementsXx_NEWLINE_xXAbility to give informed consent; for subjects < 18 years old their legal guardian must give informed consent; pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those >= 12 years of age, when appropriateXx_NEWLINE_xXAll patients or their legal representative (for patients < 18 years old) must sign an Institutional Review Board (IRB) approved informed consent document (cGVHD natural history protocol 04-C-0281 or any National Cancer Institute [NCI] protocol allowing for screening procedures) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal representative must sign the protocol specific informed consent; for pediatric patients age appropriate assent will be obtained in accordance with NIH guidelinesXx_NEWLINE_xXAbility and willingness to participate in the informed consent process and including signing a copy of the informed consent formXx_NEWLINE_xXMust sign informed consent, witnessed, and dated prior to entryXx_NEWLINE_xXSubject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explainedXx_NEWLINE_xXSubject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explainedXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must give documented informed consent to participate in this studyXx_NEWLINE_xXInformed consent must be obtained from all subjects prior to beginning therapyXx_NEWLINE_xXAll participating patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota Committee on the Use of Human Subjects in ResearchXx_NEWLINE_xXPatient or legal guardian must be able to give informed consentXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXAged ?18 years at signing of informed consent.Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXProvision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.Xx_NEWLINE_xXVenous thromboembolism within 6 months prior to signing Informed Consent Form.Xx_NEWLINE_xXAbility to understand and the willingness to participate in clinical research and comply with protocol procedures as evidenced by their signature on the informed consent formXx_NEWLINE_xXLack of parents'/guardian's informed consent for children who are minors.Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting the release of personal health informationXx_NEWLINE_xXWritten informed consent and/or assent from patient, parent or guardian.Xx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirementsXx_NEWLINE_xXWritten informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.Xx_NEWLINE_xXSubject or his/her legally authorized representative or guardian understands and voluntarily signs an informed consent document prior to any study related assessments/procedures are conducted (except as noted in Section 6).Xx_NEWLINE_xXAged ?18 years at signing of informed consentXx_NEWLINE_xXWritten informed consent by the patient (or legal representative) prior to admission to this study. In addition any locally required authorization (Health Insurance Portability and Accountability Act in the USA [HIPAA], obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.Xx_NEWLINE_xXPatients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health information; individuals with impaired decision-making capacity are not eligible to participate on the studyXx_NEWLINE_xXWritten informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.Xx_NEWLINE_xXAbility to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial activitiesXx_NEWLINE_xXPatients participating through United States (U.S.) sites must sign an approved and authorization permitting release of personal health informationXx_NEWLINE_xXMentally incompetent or unable or not willing to give written informed consent or meet study requirementsXx_NEWLINE_xXAge ? 65 years at the time of signing the informed consent form (ICF). 11. Central confirmation of diagnosis of one of the following untreated AML as per WHO classification (Appendix I):Xx_NEWLINE_xXSubject is considered an adult according to local regulation at the time of signing informed consent.Xx_NEWLINE_xXPatients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.Xx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is less than 18 years old, an Assent form and parental/guardian Consent form (replacing \you will\ with \your child will\ will be required).Xx_NEWLINE_xXAbility of patient or durable power of attorney (DPA) for healthcare to give informed consentXx_NEWLINE_xXRead, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.Xx_NEWLINE_xXMust provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluationsXx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirementsXx_NEWLINE_xXhave undergone ASCT within the period ? 3 months prior to signing the informed consent form.Xx_NEWLINE_xXHave the ability to understand the requirements of the study, provide written informed consent, which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.Xx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures.Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health informationXx_NEWLINE_xXWillingness and ability to consent for self to participate in studyXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXWritten, informed consent and assent following guidelines of the Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP)Xx_NEWLINE_xXAltered mental status precluding understanding of the informed consent process and/or completion of the necessary studiesXx_NEWLINE_xXThe patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entryXx_NEWLINE_xXSubject must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained; andXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXWritten informed consent and any locally required authorization (eg, HIPAA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.Xx_NEWLINE_xXAll subjects or their legally authorized representative must be informed of the investigational nature of the study and provide written informed consent and HIPAA authorization for release of personal health information before performance of any study related procedure not part of routine medical care. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirementsXx_NEWLINE_xXEach participant (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Consent is to be obtained prior to the initiation of any study related tests or procedures that are not part of standard of care for the participant's diseaseXx_NEWLINE_xXA signed Patient Authorization Form (HIPAA) has been obtained prior to registrationXx_NEWLINE_xXPatient is an adult male/female ? 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXAgree to study specific informed consent and HIPAA authorization for release of personal health informationXx_NEWLINE_xXSubjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to themXx_NEWLINE_xXSigned informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health information.Xx_NEWLINE_xXSigned and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislationXx_NEWLINE_xXAble to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXDementia or altered mental status that would prohibit the understanding of informed consentXx_NEWLINE_xXDiagnosis of psychiatric or addictive disorders that would preclude obtaining informed consentXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXSubjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to themXx_NEWLINE_xXFollowing receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.Xx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXPatient must be capable of understanding and complying with protocol requirements and is willing to give informed consentXx_NEWLINE_xXWritten informed consent and HIPAA authorization for release of personal health information.Xx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXAutologous HCT < 3 months prior to the time of signing the informed consent formXx_NEWLINE_xXMDS subjects may not receive RIC and must be < 50 years of age at the time of signing the informed consent formXx_NEWLINE_xXSubject is considered an adult according to local regulation at the time of obtaining informed consent.Xx_NEWLINE_xXThey or their legal guardian must give their informed consentXx_NEWLINE_xXWritten, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) GuidelinesXx_NEWLINE_xX(Turnstile 1 & Turnstile 2) Willing and able to give informed consent.Xx_NEWLINE_xXCapable of giving informed consentXx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.)Xx_NEWLINE_xXSubjects with dementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocol, or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXSigned and dated written informed consent prior to admission to the study in accordance with international conference on harmonization (ICH)-good clinical practice (GCP) guidelines and to the local legislationXx_NEWLINE_xXSubject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXPatients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health informationXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXWilling and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacementXx_NEWLINE_xXWritten informed consent and authorization obtained from the subject/Health Insurance Portability and Accountability Act (HIPAA)-appointed legal representative prior to performing any protocol-related procedures including screening evaluationsXx_NEWLINE_xXAny condition that would prohibit the understanding or rendering of information and consent and compliance with the requirements of this protocolXx_NEWLINE_xXCapable of giving written informed consent, which includes compliance with the requirements and restrictionsXx_NEWLINE_xXAny condition that would preclude informed consent, consistent follow-up and compliance for the study participationXx_NEWLINE_xXPatients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.Xx_NEWLINE_xXHas any mental or medical condition that prevents the subject from giving informed consent or participating in the trialXx_NEWLINE_xXRefuses to give informed consentXx_NEWLINE_xXBe willing and able to provide written informed consent/assent and authorization permitting study-related release of personal health informationXx_NEWLINE_xXELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Patients must be able to give informed consentXx_NEWLINE_xXBe willing and able to provide written informed consent for the trial and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXAny mental or medical condition that prevents the subject from giving informed consent or participating in the trial.Xx_NEWLINE_xXWritten informed consent and HIPAA authorization for release of personal health informationXx_NEWLINE_xXPatient has dementia or altered mental status that would prohibit the understanding or rendering of informed consent.Xx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXPatient understands the procedures and agrees to comply with the study requirements by providing written informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting the release of personal health informationXx_NEWLINE_xXPatient will read, understand and sign the informed consent and Health Insurance Portability and Accountability Act (HIPAA) agreementXx_NEWLINE_xXPatient is, at the time of signing informed consent, a regular user (including “recreational use”) of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirementsXx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessmentsXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines to ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) regulationsXx_NEWLINE_xXAny medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures.Xx_NEWLINE_xXPsychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.Xx_NEWLINE_xXWritten informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representativesXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.Xx_NEWLINE_xXPatients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).Xx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).Xx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).Xx_NEWLINE_xXWritten authorization for use and release of health and research study information (United States [US] sites only) has been obtainedXx_NEWLINE_xXPsychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study proceduresXx_NEWLINE_xXUnable to give informed consent or comply with clinical trial requirementsXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.Xx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXWritten informed consent and HIPAA authorization for release of personal health information. HIPAA authorization may be included in the informed consent or may be obtained separately. NOTE: Central pathology review may be conducted any time after definitive surgery. Consenting participants may be pre-registered to the study and proceed with central pathology review before full eligibility has been confirmed. However ALL of the eligibility criteria must be met and formal study registration completed prior to submission of the sample for sequencing.Xx_NEWLINE_xXWritten informed consent obtained from subject and ability for subject to comply with the requirements of the study.Xx_NEWLINE_xXHas any medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol, or complete the study.Xx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXWritten Authorization for Use and Release of Health and Research Study Information (United States [US] sites only) has been obtainedXx_NEWLINE_xXWritten authorization for use and release of health and research study information (Health Insurance Portability and Accountability Act [HIPAA] authorization per institutional requirements)Xx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXPsychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study proceduresXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocolXx_NEWLINE_xXInformed consent must be obtained prior to study initiationXx_NEWLINE_xXPatients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).Xx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).Xx_NEWLINE_xXSigned written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelinesXx_NEWLINE_xXWritten Authorization for Use and Release of Health and Research Study Information has been obtainedXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulationsXx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening proceduresXx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures.Xx_NEWLINE_xXPatients must have the ability to understand the study, its risks, side effects, potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).Xx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).Xx_NEWLINE_xXInformed consent and authorization for the release of health information signed by the patientXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXWilling and able to provide written informed consent and authorization for use and release of health and research study information (Health Insurance Portability and Accountability Act [HIPAA] authorization)\r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXAble to participate in the informed consent processXx_NEWLINE_xXMust be ? 18yrs at the time of signing informed consent.Xx_NEWLINE_xXSigned and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.Xx_NEWLINE_xXWillingness to provide consent for biopsy sample (dose-expansion only)Xx_NEWLINE_xXPatient must be capable of understanding and complying with protocol requirements and is willing to give informed consentXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)Xx_NEWLINE_xXAbility and willing to give consentXx_NEWLINE_xXProvide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performedXx_NEWLINE_xXWritten informed consent obtained from the patient prior to performing any study-related procedures, including screening visits; available computed tomography (CT) scans, bone scans, and labs performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 4 weeks of the first dose of AVX901; available multi gated acquisition scan (MUGA), echocardiogram, and electrocardiogram (EKG) performed as standard of care prior to signing consent can be used to fulfill eligibility requirements if they were performed within 8 weeks of the first dose of AVX901Xx_NEWLINE_xXThe patient must be willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirementsXx_NEWLINE_xXPatients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXAn approved informed consent and authorization permitting release of personal health information must be signed by patient or guardianXx_NEWLINE_xXSubject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consentXx_NEWLINE_xXPatients with dementia or an altered mental state that would preclude the understanding and rendering of informed consentXx_NEWLINE_xXAble and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXSubjects must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-upXx_NEWLINE_xXCapable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent and Health Insurance Portability and Accountability Act (HIPAA) consentXx_NEWLINE_xXBefore any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read; then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnelXx_NEWLINE_xXPatient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the studyXx_NEWLINE_xXPatients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.Xx_NEWLINE_xXPatients must have signed an authorization for the release of their protected health information.Xx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXSigned written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consentXx_NEWLINE_xXAn approved Informed Consent and authorization permitting release of personal health information must be signed by the patient or guardianXx_NEWLINE_xXPatients with dementia or altered mental status that would preclude understanding and rendering of informed consentXx_NEWLINE_xXAbility to give informed consent; for recipients and donors < 18 years of age, their legal guardian must give informed consent; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelinesXx_NEWLINE_xXMATCHED RELATED DONOR: Age >= 2 and =< 60 years old and able to give consent or assent; for donors < 18 years old, the legal guardian must be able to provide informed consent and an evaluation by a licensed social worker (LSW) or psychiatric personnel will be needed to determine willingness to participate; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelinesXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocolXx_NEWLINE_xXPatient must be capable of, and must voluntarily agree to participate by giving written informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAbility to understand and the willingness of the patient, parent or legal guardian to provide informed consentXx_NEWLINE_xXPatients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consentXx_NEWLINE_xXAny psychiatric condition that would prohibit understanding or rendering of informed consent.Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal informationXx_NEWLINE_xXEach patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXThe subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. The subject must provide study specific informed consent prior to any protocol procedures that are not a part of standard care, including consent for assessment of HLA-A2 status, mandatory tissue submission for MAGE-A3 analysis and correlative studies.Xx_NEWLINE_xXWritten informed consent and any locally-required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXPsychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consentXx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding and giving of informed consentXx_NEWLINE_xXPsychiatric or addictive disorders that would preclude obtaining informed consentXx_NEWLINE_xXWritten informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXAny medical condition, that would prevent the subject from signing the informed consent form.Xx_NEWLINE_xXPatient or parent/guardian capable of providing informed consentXx_NEWLINE_xXsigned informed consent for the HIFU treatment study through the 12 month follow-up visit (7 visits) and then through the extended follow-up period of 5 years (4 additional visits);Xx_NEWLINE_xXThe patient or legal guardian is able to give informed consentXx_NEWLINE_xXPatient or legal guardian must be able to give informed consentXx_NEWLINE_xXDONOR: Ability to give informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n*NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXSubjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.Xx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXDONOR: Ability to give informed consentXx_NEWLINE_xXWritten, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelinesXx_NEWLINE_xXSubject has received previous systemic therapy for Hepatocellular carcinoma including sorafenib, chemotherapy and investigational agents 2. Subject has received any local anticancer therapy ? 4 weeks prior to baseline tumor evaluation 3. Subject has undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks prior to signing the Informed Consent Form or who have not recovered from surgery 4. Subject has received an investigational drug or therapy for disease other than Hepatocellular carcinoma within the last 4 weeks or 5 half-lives, whichever is shorter, prior to signing the Informed Consent Form 5. Subject has completed any radiation treatment less than 2 weeks prior to signing the Informed Consent Form 6. Subject has received the last dose of ?-interferon, ribavirin, sofobuvir and/or other antiviral therapies for Hepatitis C Virus (HCV) less than 4 weeks prior to signing the Informed Consent Form 7. Subject has any clinically significant bleeding, including bleeding from esophageal/gastric varices within ? 3 months of signing the informed consent form, which required transfusion, surgical procedure or hospitalization. Esophageal varices should be treated according to local standard practice (eg, ligation or banding and procedure completed ? 3 months prior to signing the informed consent form). See Inclusion Criterion 10 8. Subjects requiring therapeutic anticoagulation with either warfarin or low molecular weight heparin. Low dose low molecular weight heparin for catheter maintenance are permitted 9. Subject has tumor invasion of stomach or duodenum 10. Subject has histologic proof of fibrolamellar carcinoma 11. Subjects with known symptomatic brain metastasis 12. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) malabsorption ? National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of either study drug 13. Subject has history of concurrent second cancers requiring active, ongoing systemic treatment. 14. Subject has a known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory) 15. Subject has peripheral neuropathy of at least NCI CTCAE Grade 2 16. Subject has a history of persistent skin rash of at least NCI CTCAE Grade 2 17. Subject has impaired cardiac function or clinically significant cardiac disease including any of the following:Xx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXSubject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.Xx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXWritten informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.Xx_NEWLINE_xXDONOR: Ability to understand and provide informed consent for all study procedures including partial liver transplant and bone marrow harvestXx_NEWLINE_xXDONOR: Ability to understand and provide informed consent for all study procedures including liver transplant and bone marrow harvestXx_NEWLINE_xXWilling and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXAble to give informed consent, or their legally authorized representative can give informed consentXx_NEWLINE_xXAny condition that may compromise the ability to give written informed consent or to comply with the study protocol.Xx_NEWLINE_xXPsychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study proceduresXx_NEWLINE_xXCompetent to give informed consentXx_NEWLINE_xXStudy subjects must sign an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA).Xx_NEWLINE_xXAny condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.).Xx_NEWLINE_xXPsychiatric conditions/diseases that impair the ability to give informed consent or to adequately co-operateXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).Xx_NEWLINE_xXPatients must give documented informed consent to participate in this studyXx_NEWLINE_xXDementia or altered mental status that would prohibit informed consentXx_NEWLINE_xXDementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health informationXx_NEWLINE_xXMust have provided informed consent for study participation.Xx_NEWLINE_xXAble and willing to sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXAbility to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information; NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXAbility and willingness to give informed consent and ability to return to the study clinic during the study periodXx_NEWLINE_xXhave psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.Xx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXAny condition that would interfere with the ability to give informed consent or comply with the study protocolXx_NEWLINE_xXAbility to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assentXx_NEWLINE_xXPatient or patient’s legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study 2006-0676Xx_NEWLINE_xXWilling and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study.Xx_NEWLINE_xXAbility to understand and the willingness to sign a written informed consent document and follow the guidelines of the clinical protocol including visits to National Cancer Institute (NCI), Bethesda, Maryland for treatment and follow up visitsXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.Xx_NEWLINE_xXDementia or altered mental status that would prohibit the understanding or rendering of informed consent.Xx_NEWLINE_xXSCREENING: Patients must be willing to sign an informed consent and undergo resection of their malignancies at the National Cancer Institute (NCI), to ensure vaccine developmentXx_NEWLINE_xXLack of ability or willingness to give informed consentXx_NEWLINE_xXFemales or males, aged >=18 years at the time of signing the informed consent form (ICF).Xx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessmentsXx_NEWLINE_xXPatient must provide written authorization to allow the use and disclosure of their protected health information at any institution subject to United States (US) Health Insurance Portability and Accountability Act (HIPAA) regulationsXx_NEWLINE_xXPatient (or legal representative where appropriate) must be capable of providing written informed consent.Xx_NEWLINE_xXPatient is capable of giving informed consent.Xx_NEWLINE_xXWritten informed consent which is consistent with International Conference on Harmonization, Good Clinical Practice (ICH-GCP) guidelines and local legislation.Xx_NEWLINE_xXSigned informed screening consent form with Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* Research personnel will review medical records of subjects consenting to screening to ensure no obvious factors would exclude them from the treatment portion of the study (e.g., history of cirrhosis of the liver) and to confirm diagnosis and stagingXx_NEWLINE_xXWritten informed consent and HIPAA authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXMen and women ? 18-years-old on the day of signing informed consent.Xx_NEWLINE_xXResearch participant or legal guardian/representative must be willing to give written informed consentXx_NEWLINE_xXPatient or his or her legal representatives must give written informed consent and privacy authorization prior to participation in the study.Xx_NEWLINE_xXWritten patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.Xx_NEWLINE_xXWilling to adhere to protocol specific requirements 12. Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out. 13. Clinically significant toxic effects of prior therapy (expect hydroxyuria) resolved to Grade ? 1 before the start of study.Xx_NEWLINE_xXPatients must have the ability to give informed consentXx_NEWLINE_xXFollowing receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.Xx_NEWLINE_xXSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.Xx_NEWLINE_xXPatients must have the ability to give informed consentXx_NEWLINE_xXWritten informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.Xx_NEWLINE_xXSubject has psychiatric disorder or altered mental status that would preclude an understanding of the informed consent process and/or completion of the necessary study procedures.Xx_NEWLINE_xXSubjects with altered mental status that would prohibit the giving and understanding of informed consent, and assent when applicable, who do not have a legally authorized representative.Xx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXAny condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.Xx_NEWLINE_xXDementia or significantly altered mental status that would prohibit the understanding or rendering of information and consent and compliance with the requirements of the protocolXx_NEWLINE_xXResearch participant or legal guardian/representative is able and willing to give written informed consentXx_NEWLINE_xXWritten informed consent that is consistent with ICH-GCP guidelines and local regulationsXx_NEWLINE_xXSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXSigned and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollmentXx_NEWLINE_xXCapable of compliance with the requirements and restrictions listed in the consent form;Xx_NEWLINE_xXA written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF).Xx_NEWLINE_xXSubject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Institutional Review Board-approved Informed Consent Form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.Xx_NEWLINE_xXCapable of providing informed consent and complying with trial procedures.Xx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXDONOR: Ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvestXx_NEWLINE_xXCapable of providing informed consent and complying with trial procedures.Xx_NEWLINE_xXWritten informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXSubject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.Xx_NEWLINE_xXSigned informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial informationXx_NEWLINE_xXPatients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consentXx_NEWLINE_xXThe subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities.Xx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments.Xx_NEWLINE_xXPatients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.Xx_NEWLINE_xXProvision of informed consentXx_NEWLINE_xXPsychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.Xx_NEWLINE_xXSignificant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the studyXx_NEWLINE_xXEligible to give informed consent to participate in the study.Xx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXPART I: Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participateXx_NEWLINE_xXPART II: Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participateXx_NEWLINE_xXSerious medical condition that would impair the ability to receive or tolerate margetuximab; dementia or altered mental status that would preclude provision of informed consentXx_NEWLINE_xXLack of ability or willingness to give informed consent.Xx_NEWLINE_xXPatients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.Xx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXPatients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligibleXx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for required assessments.Xx_NEWLINE_xXWillingness to consent to research biopsyXx_NEWLINE_xXMales / females, ? 18 years old, any race / ethnicity, who can provide written Informed ConsentXx_NEWLINE_xXCognitive impairment sufficient to render the patient incapable of giving informed consentXx_NEWLINE_xXHave the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.Xx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirementsXx_NEWLINE_xXA written and voluntarily signed informed consent must be obtained from the patient or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The patient or legally authorized representative must be able to read and understand the informed consent form (ICF).Xx_NEWLINE_xXEncephalitis, meningitis, or uncontrolled seizures in the year prior to informed consentXx_NEWLINE_xXDiagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < 18 years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patient’s research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtainedXx_NEWLINE_xXPatients must sign study-specific informed consent and authorization for the release of their protected health information prior to registration; patients must be registered in the prior to treatment with study drugXx_NEWLINE_xXPatient consent must be appropriately obtained in accordance with applicable local and regulatory requirements; each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\r\n* A similar process must be followed for sites outside of Canada as per their respective cooperative group’s proceduresXx_NEWLINE_xXPatients must be female, be ? 18 years of age, be able to understand the study procedures, and agree to participate in the study by providing written informed consent.Xx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXPatients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problemsXx_NEWLINE_xXAny other condition, including mental illness or substance abuse deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate, and participate in the studyXx_NEWLINE_xXOn a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.Xx_NEWLINE_xXIf under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)Xx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXPatients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligibleXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulationsXx_NEWLINE_xXWritten informed consent which is consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.Xx_NEWLINE_xXHave the ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study and follow-up procedures.Xx_NEWLINE_xXAny significant psychological, medical, or surgical condition thought to compromise the participant, the study, or prevent informed consentXx_NEWLINE_xXSubjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol, or legally acceptable representative willing and able to give written informed consent on behalf of the subject for minors, unconscious adults and those incapable of consenting themselves due to their medical condition, or included as permitted by local regulatory authorities, IRB/IECs or local laws.Xx_NEWLINE_xXAn approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardianXx_NEWLINE_xXCapable of given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.Xx_NEWLINE_xXThe patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.Xx_NEWLINE_xXWritten informed consent and HIPAA authorization for release of personal health information.Xx_NEWLINE_xXPatient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen yearsXx_NEWLINE_xXParental informed consentXx_NEWLINE_xXPatient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen yearsXx_NEWLINE_xXDONOR: Ability to give informed consentXx_NEWLINE_xXAll patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility) (Cohort 1)Xx_NEWLINE_xXAll patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)Xx_NEWLINE_xXPatients must sign an authorization for the release of their protected health informationXx_NEWLINE_xXPatient has given written informed consent which must be consistent with the International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local legislation.Xx_NEWLINE_xXAble to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject's privacy regulations).Xx_NEWLINE_xXThe patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.Xx_NEWLINE_xXSubject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study proceduresXx_NEWLINE_xXPatients must be capable of signing an informed consentXx_NEWLINE_xXWritten informed consent obtained from subject or subject’s legal representative and ability for subject to comply with requirements of the studyXx_NEWLINE_xXDocumented informed consent of the participant and/or legally authorized representativeXx_NEWLINE_xXEach subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the studyXx_NEWLINE_xXWritten informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization) obtained from the subject prior to performing any protocol-related procedures, including screening evaluationsXx_NEWLINE_xXMental impairment that may compromise the ability to give informed consent and comply with the requirements of the studyXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization form permitting the release of personal health informationXx_NEWLINE_xXAbility to provide written informed consent for the protocol must be obtained prior to any screening procedures; if consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witnessXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the studyXx_NEWLINE_xXPatients must be able to render informed consent and must consent to participate in the trialXx_NEWLINE_xXInformed consent and Health Insurance Portability and Accountability Act (HIPAA) signingXx_NEWLINE_xXWritten consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trialXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXAble to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit; if the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enrollXx_NEWLINE_xXPATIENT: They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participationXx_NEWLINE_xXCapable of providing informed consentXx_NEWLINE_xXAdult patients who are capable of giving consentXx_NEWLINE_xXUnable to provide meaningful consent (e.g., severe cognitive impairment)Xx_NEWLINE_xXWomen with cognitive impairment that precludes informed consent and those unable to provide consent in EnglishXx_NEWLINE_xXProviding informed consentXx_NEWLINE_xXPATIENT EXCLUSION: Unable to provide informed consent or complete study procedures as determined by clinical or study staffXx_NEWLINE_xXCAREGIVER EXCLUSION: Unable to provide informed consent or complete study procedures as determined by clinical or study staffXx_NEWLINE_xXWilling and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information \r\n* NOTE: HIPAA authorization may be either included in the informed consent or obtained separatelyXx_NEWLINE_xXThose mentally or physically unable to read the consent form or other study materials and/or participate in the consent and engagement with the CaringGuidance program; women who have been hospitalized for mental health issues or substance abuse in the past year are ineligibleXx_NEWLINE_xXPHASE I: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consentXx_NEWLINE_xXPHASE II: For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consentXx_NEWLINE_xXHave parental consent to participateXx_NEWLINE_xXLack of ability to give informed consentXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXPatient must have given written informed consent according to Food and Drug Administration (FDA) guidelinesXx_NEWLINE_xXPatient or parent(s)/legal guardian(s) is able and willing to provide informed consent; assent will be obtained per local institutional policy; subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staffXx_NEWLINE_xXSubject has provided informed consent.Xx_NEWLINE_xXSubject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP guidelines and applicable local regulations.Xx_NEWLINE_xXBoth men and women in the rituximab combination arm (Cohort B) must practice contraception as described above from the time of signing of the informed consent form (ICF) through 12 months after the last dose of study drug.Xx_NEWLINE_xXAny psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXAbility to understand and/or the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedureXx_NEWLINE_xXSubject understands and signs the Informed ConsentXx_NEWLINE_xXThey have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participationXx_NEWLINE_xXCapable of giving informed consentXx_NEWLINE_xXPatients who are incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team or the exercise physiologist, or have been treated for another cancerXx_NEWLINE_xXCognitively able to consent to participateXx_NEWLINE_xXFCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participationXx_NEWLINE_xXPatients with obvious unresectable disease prior to signing informed consentXx_NEWLINE_xXPeople unable to read and understand the informed consent document because of language difficultiesXx_NEWLINE_xXSubjects must be capable of giving informed consentXx_NEWLINE_xXCapable of giving informed consentXx_NEWLINE_xXPatients who are incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research teamXx_NEWLINE_xXSubjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject’s behalfXx_NEWLINE_xXThe patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the United States (U.S.) Department of Health and Human Services; informed consent must be signed prior to registration on studyXx_NEWLINE_xXThe participant understands and is willing to provide informed consent in English or SpanishXx_NEWLINE_xXPROVIDER ELIGIBILITY: The participant is willing to provide informed consent in EnglishXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXLymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status QuestionnaireXx_NEWLINE_xXNo Lymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status QuestionnaireXx_NEWLINE_xXAbility to give informed consent.Xx_NEWLINE_xXSignificant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the studyXx_NEWLINE_xXSignificant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the studyXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXCognitively unable to give informed consentXx_NEWLINE_xXSevere cognitive dysfunction impairing ability to provide informed consent or consume study drugXx_NEWLINE_xXPatients that consent to participateXx_NEWLINE_xXThe patient for whom they are a caregiver does not consent to participateXx_NEWLINE_xXIn the judgment of the consenting professional cognitively able to provide informed consentXx_NEWLINE_xXReceiving elotuzumab and/or other study drugs at the time of signature of informed consentXx_NEWLINE_xXIn the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessmentXx_NEWLINE_xXTreating oncologist consentXx_NEWLINE_xXPatient must give informed consent for this new studyXx_NEWLINE_xXIn the judgment of the consenting professional cognitively able to provide informed consentXx_NEWLINE_xXIn the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessmentXx_NEWLINE_xXNot giving consent for study participationXx_NEWLINE_xXAny physical or mental health condition that would interfere with full participation in the study, including individuals who are unable to read consent materials or appear to lack the capacity to consentXx_NEWLINE_xXYBCS: Able to consent to the studyXx_NEWLINE_xXHCP: Able to consent to the studyXx_NEWLINE_xXDCG: Is capable of providing informed consentXx_NEWLINE_xXConsent to the study; andXx_NEWLINE_xXInformed consent must be obtained prior to any study-related procedures; consent will be obtained from a parent or guardian of eligible subjects, or the patient if >= 18 years old; oral assent will be obtained from minor subjects >= 7 years old, unless more stringent requirements are imposed by a site’s local institutional review boardXx_NEWLINE_xXProviding informed consentXx_NEWLINE_xXTreating oncologist consentXx_NEWLINE_xXWith sufficient ability to communicate in English in order to provide informed consent and complete study procedures and materialsXx_NEWLINE_xXMedical record documentation of cognitive impairment that would preclude the ability to provide informed consentXx_NEWLINE_xXSubjects are capable of giving informed consentXx_NEWLINE_xXInability to provide informed consent in English or Spanish as determined by trained mental health professional study personnelXx_NEWLINE_xXPatients with suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the investigator to be likely to affect their ability to sign the informed consent, or undergo study procedures will be excludedXx_NEWLINE_xXSignificant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consentXx_NEWLINE_xXSUPPORT PROVIDER: Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consentXx_NEWLINE_xXRefusal of informed consentXx_NEWLINE_xXWomen with psychological, psychiatric, or other conditions which prevent giving fully informed consentXx_NEWLINE_xXDocumented informed consent of the participant and/or legally authorized representativeXx_NEWLINE_xXSubjects are capable of giving informed consent.Xx_NEWLINE_xXBe willing to provide written informed consent to participate in the study which includes several clinical evaluations, provide access to medical records/primary care physician (PCP), and allow all interviews and PSST therapy sessions to be audiotaped.Xx_NEWLINE_xXSignificant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient’s ability to participate in the informed consent proceduresXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXThis protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consentXx_NEWLINE_xXThis protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consentXx_NEWLINE_xXPatients who are confused and unable to give informed consentXx_NEWLINE_xXPatients will have provided informed consent to participate, documented by their signature on the study consent formXx_NEWLINE_xXSigned Health Insurance Portability and Accountability Act (HIPAA) compliant research authorizationXx_NEWLINE_xXAble to provide informed consent or, if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (per institutional policies) must sign consent by the baseline visitXx_NEWLINE_xXCognitive impairment or mental illness that would impair ability to provide consent or participate in the programXx_NEWLINE_xXDementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXAble to provide written informed consent and authorization for release of health informationXx_NEWLINE_xXAble to undergo informed consent procedures and 3 hours of testing, plus 8 1-hour cognitive rehabilitation sessions with breaksXx_NEWLINE_xXMen and women with literacy as demonstrated by reading and signing informed consent formXx_NEWLINE_xXCo-morbid delirium, dementia, mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study proceduresXx_NEWLINE_xXPresence of relatively intact cognition defined by normal memorial delirium assessment scale (< 7/30); sign written informed consentXx_NEWLINE_xXNeurocognitive deficits that impair ability to give informed consentXx_NEWLINE_xXIndividuals who lack the capacity to consent will be excluded from this studyXx_NEWLINE_xXAbility to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)Xx_NEWLINE_xXHas the ability to read and understand subject Informed Consent Form (ICF).Xx_NEWLINE_xXPatients and caregivers must both be able to give informed consentXx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act of 1966 (HIPAA) authorization for release of personal health information.Xx_NEWLINE_xXParticipants must be capable of understanding and complying with the protocol requirements and signing informed consentXx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXUnable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXPatients with psychiatric or addictive disorders that would preclude obtaining informed consentXx_NEWLINE_xXCapable of providing informed consentXx_NEWLINE_xXPatients must give informed consent according to the rules and regulations of the individual participating sitesXx_NEWLINE_xXPatient is unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations; a legal representative can consent on behalf of a patient who is able to understand the purpose and risk of the study but not able to provide a signature on the ICF and authorization to use PHI due to neurologic deficits (e.g. motor or language deficits)Xx_NEWLINE_xXPsychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q questionnairesXx_NEWLINE_xXCaregiver exhibits significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participationXx_NEWLINE_xXWilling and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire, use of antipsychotic medications, and suicidal ideationsXx_NEWLINE_xXLegally authorized representative consentXx_NEWLINE_xXPatients able to render informed consent and to follow protocol requirementsXx_NEWLINE_xXSignificant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the groups (i.e., acute psychiatric symptoms which require individual treatment)Xx_NEWLINE_xXSubjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consentXx_NEWLINE_xXSignificant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the studyXx_NEWLINE_xXSigned HIPAA compliant research authorization (or equivalent for international sites) to release Personal Health Information to the SunCoast CCOP Research Base must be obtained prior to registrationXx_NEWLINE_xXMedical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or orthopedic history that would prohibit a program of walking for exercise; psychotic disorders, dementia, inability to give informed consent)Xx_NEWLINE_xXDiagnosis of dementia or unable to grant their own informed consentXx_NEWLINE_xXAbility to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXWilling to consent to participateXx_NEWLINE_xXDementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXThe patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study, as has his/her responsible caregiver, if applicableXx_NEWLINE_xXPatient or legal representative must consent to multi-bio-frequency impedance analysis (MFBIA); the details are to be covered in consentXx_NEWLINE_xXPatient or legal guardian willing to sign consent for skin biopsies and phlebotomyXx_NEWLINE_xXWritten informed consent obtained in accordance with institutional policies approved by the United States (U.S.) Department of Health and Human ServicesXx_NEWLINE_xXIncapable of giving informed consentXx_NEWLINE_xXPatients must sign an informed consent before data collection, screening, or initiation of study proceduresXx_NEWLINE_xXParent or legal guardian consentXx_NEWLINE_xXThis protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consentXx_NEWLINE_xXSubject or authorized representative has provided informed consent.Xx_NEWLINE_xXParticipant/parent/legally authorized representative (LAR) unwilling to give written informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health informationXx_NEWLINE_xXPeople unable to read and understand the informed consent document because of language difficultiesXx_NEWLINE_xXWillingness to give informed consentXx_NEWLINE_xXDONOR: Willingness to give informed consentXx_NEWLINE_xXPatients unable to give informed consentXx_NEWLINE_xXPatients with obvious unresectable disease prior to signing informed consentXx_NEWLINE_xXCapable of giving informed consentXx_NEWLINE_xXAll subjects must have the ability to understand and the willingness to sign a written informed consent that has been approved by the City of Hope (COH) Institutional Review Board (IRB); the patient, a family member and transplant staff physician (physician, nurse, and social worker) will meet at least once prior to the subject signing consent; during this meeting all pertinent information with respect to risks and benefits to donor and recipient will be presented; alternative treatment modalities will be discussed; the risks are explained in detail in the enclosed consent formXx_NEWLINE_xXDementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consentXx_NEWLINE_xXSubjects who are unable to give informed consentXx_NEWLINE_xXDocumented informed consent of the participantXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXPatients who are unable to give informed consentXx_NEWLINE_xXSubjects capable of giving informed consentXx_NEWLINE_xXAny patient/volunteer unable to give informed consentXx_NEWLINE_xXMust be willing to complete demographic, family history, personal health and medication history, and informed consentXx_NEWLINE_xXMust be willing to keep the clinic informed of their breast health status for 10 years when requestedXx_NEWLINE_xXWritten authorization for use and release of health and research study information has been obtainedXx_NEWLINE_xXNo history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board [IRB] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) formsXx_NEWLINE_xXAdults unable to consentXx_NEWLINE_xXPatients do not have the ability to give informed consentXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health informationXx_NEWLINE_xXPatient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent.Xx_NEWLINE_xXParent/legal guardian willing and capable of signing written informed consentXx_NEWLINE_xXProvide signed informed consent and agree to comply with all protocol-specified procedures (e.g., providing saliva samples; participating in five one-hour group sessions over a period of 22 days) and follow-up evaluationsXx_NEWLINE_xXEXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXPresence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgementXx_NEWLINE_xXWillingness to give informed consentXx_NEWLINE_xXDONOR: Willingness to give informed consentXx_NEWLINE_xXAn approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardianXx_NEWLINE_xXUnwilling to give informed consentXx_NEWLINE_xXA willingness to follow the study protocol, as indicated by provision of informed consent to participateXx_NEWLINE_xXParticipant has a known diagnosis of mental incapacitation that may affect their ability to consent and be compliant with the protocolXx_NEWLINE_xXSubjects consent to participate in the trialXx_NEWLINE_xXSMOKING CESSATION SUB-STUDY: Written informed consent will be obtained by trained study personnel from all participantsXx_NEWLINE_xXParticipants who exhibit confusion, disorientation, or have a history of major psychiatric illness which may impair their understanding of the informed consentXx_NEWLINE_xXParticipation in any study with an investigational compound or device within 30 days prior to signing informed consentXx_NEWLINE_xXSubjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to themXx_NEWLINE_xXPatients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)Xx_NEWLINE_xXSigned written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening proceduresXx_NEWLINE_xXPatient, parent/guardian able to give informed consentXx_NEWLINE_xXWritten informed consent and authorization to use and disclose health informationXx_NEWLINE_xXProvision of informed consent by primary caregiverXx_NEWLINE_xXSubject consent and authorization for the release of health information must be obtained according to local institutional guidelinesXx_NEWLINE_xXProvision of informed consentXx_NEWLINE_xXCapable of informed consentXx_NEWLINE_xXHas evidence of CMV viremia (if tested) at any time from either signing of the Informed Consent Form or the HSCT procedure, whichever is earlier, until the time of randomization.Xx_NEWLINE_xXAble to fully understand and participate in the informed consent processXx_NEWLINE_xXSigned informed consent by subject (age >= 18 years) or by parent/guardian (subject age < 18 years); information will be provided to potential subjects and their parents/guardians (as appropriate) by oral discussion with opportunity for question and answer and the written informed consent document; subjects less than 18 years of age capable of giving assent will be included in these discussions and will be asked for written assent on the same document as the parents/guardians give consent; if feasible, both parents (or guardians) will be included in these discussions and will be asked to sign the written consent document; if a second parent or guardian is unavailable, this will be explained in writing on the written consent document; if subjects age 18 years or older are unable to provide informed consent, then they will not be enrolled in this studyXx_NEWLINE_xXThe patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXIndividuals able to give informed consent, or a signature from a designated health care proxy or legal guardianXx_NEWLINE_xXAbility to understand and the willingness of the patient, parent or legal guardian to provide informed consentXx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessmentsXx_NEWLINE_xXAll subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXParticipant will be fully informed and has personally signed and dated the written informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisionsXx_NEWLINE_xXExcluded from this study will be prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)Xx_NEWLINE_xXFor patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.Xx_NEWLINE_xXPatients who in the judgment of the investigators and/or consenting professional, are able to understand the purpose of the study and provide informed consent will be includedXx_NEWLINE_xXCannot consent for himself or herselfXx_NEWLINE_xXPatients must have signed an approved informed consent and authorization permitting release of personal health information; ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent documentXx_NEWLINE_xXPatients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality dataXx_NEWLINE_xXAll patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXPatients must lack bleeding disorders, and be able to provide informed consent; the latter two criteria will be assessed from the patient’s history and the consenting interviewXx_NEWLINE_xXAll subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXAll subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXSigning consent for study imaging procedure and analysis of prostate biopsyXx_NEWLINE_xXAbility of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.Xx_NEWLINE_xXSign written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXPatient or legal parent/guardian unable to provide informed consentXx_NEWLINE_xXPsychiatric or addictive disorders that preclude obtaining informed consentXx_NEWLINE_xXPatients who cannot consent for themselvesXx_NEWLINE_xXAble to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicableXx_NEWLINE_xXSubject or legally authorized representative signs study-related informed consent documentXx_NEWLINE_xXSubject capable of giving informed consent and participating in the process of consentXx_NEWLINE_xXUnwilling or unable to provide informed consent; only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study; individuals who are considered to be mentally disabled will not be recruited for this study; all subjects must understand and be able to give informed consent; we will not be using specific methods to assess decisional capacity; economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation; all individuals will be told that their choice regarding study participation will in no way change their access to clinical care; this should negate any undue influence or coercion; children, fetuses, neonates, or prisoners\r\nare not included in this research study; the menopausal status of the study participant will be reviewed during the screening process by examining the patient’s chart, women of childbearing potential will have a serum or urine pregnancy test at the time of screeningXx_NEWLINE_xXOnly individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this studyXx_NEWLINE_xXOnly individuals who can understand and give informed consent will be eligible to participate in this studyXx_NEWLINE_xXSubject capable of giving informed consent and participating in the process of consentXx_NEWLINE_xXUnwilling to give informed consentXx_NEWLINE_xXThe patient must provide informed written consent, which will include a layman’s explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPGXx_NEWLINE_xXCAREGIVER/PARENT: Caregivers (parents or legal guardians) must give informed consentXx_NEWLINE_xXPatients must agree to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database, as evidenced by signing the informed consent formXx_NEWLINE_xXAll patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXValid informed consent by subject or subject’s legally authorized representative (LAR)Xx_NEWLINE_xXINCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related proceduresXx_NEWLINE_xXIndividuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)Xx_NEWLINE_xXThe patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the US Department of Health and Human ServiceXx_NEWLINE_xXAll patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXAll patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXHave the ability to give informed consentXx_NEWLINE_xXWritten informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\r\n* Note: HIPAA authorization may be included in the informed consent or obtained separatelyXx_NEWLINE_xXPatient or patient's legally acceptable representative cognitively provides written informed consentXx_NEWLINE_xXunwilling to give informed consent;Xx_NEWLINE_xXHEALTHY VOLUNTEERS: Patient is willing to provide informed consentXx_NEWLINE_xXAll patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXPsychiatric or addictive disorders that preclude obtaining informed consentXx_NEWLINE_xXAble to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXParticipants must lack bleeding disorders, and be able to provide informed consent; the latter two criteria will be assessed from the patient’s history and the consenting interviewXx_NEWLINE_xXPatient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedureXx_NEWLINE_xXLOCALIZED RCC TREATED WITH PARTIAL NEPHRECTOMY:\r\nWritten informed consent availableXx_NEWLINE_xXADVANCED RCC TREATED WITH RADICAL NEPHRECTOMY:\r\nWritten informed consent availableXx_NEWLINE_xXMinors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from the studyXx_NEWLINE_xXWomen who cannot consent for themselvesXx_NEWLINE_xXPatient must provide written authorization to allow the use and disclosure of their protected health information; NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registrationXx_NEWLINE_xXAll participants, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXPatients must be able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorizationXx_NEWLINE_xXPatients who cannot consent for themselvesXx_NEWLINE_xXAbility to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical informationXx_NEWLINE_xXPatients will have provided informed consent to participate, documented by their signature on the study consent formXx_NEWLINE_xXPatients will have provided informed consent to participate, documented by their signature on the study consent formXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and procedures; unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)Xx_NEWLINE_xXWritten, informed consent and assent following Institutional Review Board, National Cancer Institute (NCI), Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidelinesXx_NEWLINE_xXAny condition that would prohibit the understanding or rendering of informed consentXx_NEWLINE_xXIs a regular user (including recreational use) of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuseXx_NEWLINE_xXAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health informationXx_NEWLINE_xXAbility to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization formXx_NEWLINE_xXAre unwilling to give informed consentXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXSubjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXSubject has provided written informed consent with HIPAA authorizationXx_NEWLINE_xXPatients incapable of giving informed written consent, due to mental disability, altered mental status,\r\nconfusion, cognitive impairment, or psychiatric disorders\r\n* Patients scoring 14.5 or lower on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) questionnaire will not be allowed on studyXx_NEWLINE_xXAll patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelinesXx_NEWLINE_xXSubjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercionXx_NEWLINE_xXBe capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visitsXx_NEWLINE_xXPatients incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders\r\n** Patients scoring 14.5 or lower on the University of California at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded\r\n* Prisoners or other individuals deemed to be susceptible to coercionXx_NEWLINE_xXSubjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercionXx_NEWLINE_xXPatient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conductedXx_NEWLINE_xXPsychiatric or addictive disorders that impair subject’s voluntary ability to participate in informed consent or protocol proceduresXx_NEWLINE_xXInformed consent cannot be obtained either from the patient or legal representativeXx_NEWLINE_xXThe patient must be considered legally capable of providing his or her own consent for participation in this studyXx_NEWLINE_xXPatient gives informed or surrogate consentXx_NEWLINE_xXAny condition that would alter the patient’s mental status, prohibiting the basic understanding and/or authorization of informed consentXx_NEWLINE_xXPatient ability to read and comprehend the informed consent documentXx_NEWLINE_xXWritten informed consent signed by all patients and/or their parents or legal guardians (both parents/guardians if reasonably available)Xx_NEWLINE_xXAbility to give informed consentXx_NEWLINE_xXValid informed consent by subjectXx_NEWLINE_xXOnly individuals who can understand and give informed consent will be eligible to participate in this study; individuals who are considered to be mentally disabled will not be recruited for this study; all subjects must understand and be able to give informed consent; we will not be using specific methods to assess decisional capacity; all individuals will be told that their choice regarding study participation will in no way change their access to clinical care; this should negate any undue influence or coercion; children, fetuses, neonates, or prisoners are not included in this research study; women of child-bearing potential will have a urine pregnancy test at the time of screeningXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXHave the ability to understand and to give written informed consent as assessed by the participant’s primary care physician or medical oncologistXx_NEWLINE_xXUnable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist.Xx_NEWLINE_xXPatients must have capacity to consentXx_NEWLINE_xXUnable to give informed consentXx_NEWLINE_xXAble to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study)Xx_NEWLINE_xXMothers need to be free of serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consentXx_NEWLINE_xXUnable to provide consent due to a mental, emotional, or physical handicap, that keep them from understanding the consent informationXx_NEWLINE_xXSignificant psychiatric or cognitive disturbance sufficient, in the consenting professional's or investigator's judgment, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment)Xx_NEWLINE_xXPatients who have provided informed consent for the long term follow up study prior to their study participation .Xx_NEWLINE_xXPatient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedureXx_NEWLINE_xXIndividuals who are unable to give informed consentXx_NEWLINE_xXWho are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy 3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential 4. Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion 5. Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessmentsXx_NEWLINE_xXInformed Consent: Written informed consent must be obtained from subject or parent/legal guardian prior to enrollment. Assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients who have initiated treatment for unresectable or metastatic melanoma at\n             medical practice (e.g. community-based, office-based, hospital-based, academic\n             setting)within 21 days before informed consent for this study OR in the case where\n             treatment has not yet been initiated, documentation that the treatment strategy was\n             determined before informed consent for this study, and treatment must be initiated\n             within 28 days after informed consentXx_NEWLINE_xXThe patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment; patients may have the assistance of an interpreter or surrogate when completing forms/surveys as neededXx_NEWLINE_xXSubject has provided written informed consent to participate in the study\n             (adolescents under the age of 18 will be excluded because this project involves\n             continued use of tobacco products and new tobacco products);Xx_NEWLINE_xXcurrently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.Xx_NEWLINE_xXAbility to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessmentsXx_NEWLINE_xXUnable to provide informed consent or high risk that patient may not comply with\n             protocol requirements (i.e. due to health and/or participation in other research\n             studies).Xx_NEWLINE_xXThe participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.Xx_NEWLINE_xXThe participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.Xx_NEWLINE_xXAbility to understand purpose and risks of the study and provide signed and dated informed consent, and authorization to use protected health informationXx_NEWLINE_xXPatients are capable of giving informed consentXx_NEWLINE_xXPatients are capable of giving informed consentXx_NEWLINE_xXSubjects participating in another clinical investigation at the time of signature of the informed consent.Xx_NEWLINE_xXSubject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.Xx_NEWLINE_xXWillingness and ability to consent for self to participate in studyXx_NEWLINE_xX