Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent processXx_NEWLINE_xXPatients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infectionXx_NEWLINE_xXPatient must not have an intercurrent illness likely to interfere with protocol therapyXx_NEWLINE_xXActive uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormalityXx_NEWLINE_xXSerious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatmentXx_NEWLINE_xXPatients with known serious concurrent infection or medical illness, including psychiatric disordersXx_NEWLINE_xXPsychiatric illness or social situation which in the opinion of the Investigator would limit compliance with trial requirements.Xx_NEWLINE_xXA medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulationsXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXPatients with a psychiatric illness, other condition or significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirements are NOT eligible for participationXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.Xx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolledXx_NEWLINE_xXELIGIBILITY CRITERIA - PHASE II (ARM D): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolledXx_NEWLINE_xXHas a serious illness or medical condition(s)Xx_NEWLINE_xXAny significant acute or chronic medical illnessXx_NEWLINE_xXHas a medical condition that requires immunosuppressionXx_NEWLINE_xXOther acute or chronic medical or psychiatric conditionXx_NEWLINE_xXSerious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluationXx_NEWLINE_xXPatients with an active infection or serious intercurrent medical illness are ineligibleXx_NEWLINE_xXSignificant intercurrent illness that will limit the patient's ability to participate in the studyXx_NEWLINE_xXOther illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the patient from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.Xx_NEWLINE_xXEvidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consentXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Severely impaired lung function\r\n* Any active (acute or chronic) or uncontrolled infection/disorders\r\n* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\r\n* Psychiatric illness/social situations that would limit compliance with study requirementXx_NEWLINE_xXPsychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.Xx_NEWLINE_xXPatient has uncontrolled intercurrent illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXConcurrent or Intercurrent Illness:Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent.Xx_NEWLINE_xXAny serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious, unstable medical or psychiatric condition that would prevent, (as judged by the investigator) the subject properly providing informed consent or any condition which would jeopardize compliance with the protocolXx_NEWLINE_xXPatients with any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol are not eligibleXx_NEWLINE_xXAny other significant medical illness, abnormality, or conditionXx_NEWLINE_xXSerious illness or medical condition.Xx_NEWLINE_xXUncontrolled intercurrent illness judged by the treating investigator to preclude treatment with chemotherapyXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study proceduresXx_NEWLINE_xXPatients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow upXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would – in the opinion of the investigator – prevent the subject from signing the informed consent formXx_NEWLINE_xXPatients who exhibit any other serious concurrent infection or other medical illness which would jeopardize their ability to receive the therapy outlined in this protocol with reasonable safety will NOT be eligible for participationXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.Xx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:Xx_NEWLINE_xXHistory or evidence of any clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor would pose a risk to the subject's safety or interfere with the study evaluations, procedures, or completion. Examples include intercurrent illness such as active uncontrolled infection, active or chronic bleeding event within 28 days of baseline, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.Xx_NEWLINE_xXSubject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety.Xx_NEWLINE_xXPresence of any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the studyXx_NEWLINE_xXSubjects must have no uncontrolled intercurrent illnessXx_NEWLINE_xXHave other life-threatening illnessXx_NEWLINE_xXSubject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXHas any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study resultsXx_NEWLINE_xXAny uncontrollable intercurrent illness, infection, or other conditions that could limit study compliance or interfere with assessments.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent study participationXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent study participationXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXSerious cardiopulmonary medical conditionXx_NEWLINE_xXMust not have a psychiatric illness, other significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirementsXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illnessXx_NEWLINE_xXPrisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illnessXx_NEWLINE_xXPatient with serious medical of psychiatric illness likely to interfere with participation on this clinical studyXx_NEWLINE_xXSerious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.Xx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXIndividuals with major medical or psychiatric illness which would prevent the completion of study treatment and/or interfere with follow up are excluded from this studyXx_NEWLINE_xXParticipant has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the protocol-specified treatment.Xx_NEWLINE_xXOther uncontrolled or poorly controlled intercurrent illness (e.g., involving the renal, hepatic, neurologic, dermatologic, pulmonary, endocrine systems) or psychiatric illness/social situations that would limit compliance with study requirements, place the subject at undue risk or confound interpretation of safety or other data.Xx_NEWLINE_xXPatients must have no serious or uncontrolled medical conditionsXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXMedical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-upXx_NEWLINE_xXHave serious preexisting medical conditions.Xx_NEWLINE_xXAny illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the treatment according to this protocol or complete the studyXx_NEWLINE_xXSevere or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, fever, systemic and/or uncontrolled infections, psychiatric illness/social situations that would limit compliance with study requirements)Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent.Xx_NEWLINE_xXAny serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXPsychiatric disorders that would interfere with consentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSevere or uncontrolled medical disorder that would, in the investigator’s opinion, confound study analyses of treatment response (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the studyXx_NEWLINE_xXOther serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.Xx_NEWLINE_xXSerious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXOther significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participateXx_NEWLINE_xXPatients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition, medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the studyXx_NEWLINE_xXUncontrolled serious medical or psychiatric illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the consent formXx_NEWLINE_xXPatients with any serious or medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illnessXx_NEWLINE_xXSerious pre-existing medical conditions as follows:Xx_NEWLINE_xXMedical suitability for resection, including documented medical and cardiac clearanceXx_NEWLINE_xXPatients with an active infection or serious intercurrent medical illness are ineligibleXx_NEWLINE_xXUncontrolled inter-current illnessXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXKnown diagnosis of human immunodeficiency virus, active chronic hepatitis B, or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this studyXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g., infectious) illnessXx_NEWLINE_xXHave serious preexisting medical conditionsXx_NEWLINE_xXMajor medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).Xx_NEWLINE_xXPatients should have NO significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocolXx_NEWLINE_xXIntercurrent illness that will interfere with the radiation therapy such as immunosuppression due to medication or medical conditionXx_NEWLINE_xXMajor medical, addictive or psychiatric illness which in the investigator’s opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)Xx_NEWLINE_xXKnown psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.Xx_NEWLINE_xXPatients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent.Xx_NEWLINE_xXPatient must not have serious medical or psychiatric illness likely to interfere with participation in this clinical study in the opinion of the investigator.Xx_NEWLINE_xXPatients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safetyXx_NEWLINE_xXKnown human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator’s opinion, potentially interfere with participation in this studyXx_NEWLINE_xXMEDICAL HISTORY AND CONCURRENT DISEASESXx_NEWLINE_xXSubjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatmentXx_NEWLINE_xXSerious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluationXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigatorXx_NEWLINE_xXPatients with any concurrent uncontrolled clinically significant medical condition, including infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.Xx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditionsXx_NEWLINE_xXPatients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.Xx_NEWLINE_xXUncontrolled concurrent serious illnessXx_NEWLINE_xXParticipants must not be compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXSubjects with a history of serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the investigator as high risk for investigational drug treatmentXx_NEWLINE_xXSignificant concurrent, uncontrolled medical conditionXx_NEWLINE_xXMajor medical illnesses or psychiatric impairments, which in the investigator’s opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-upXx_NEWLINE_xXAny mental or physical condition or disease or past medical history that mitigates against following the protocolXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (infection disease) illness.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study proceduresXx_NEWLINE_xXOther severe acute or chronic medical conditionXx_NEWLINE_xXPsychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.Xx_NEWLINE_xXActive, uncontrolled serious infection or medical or psychiatric illness, that in the investigator’s opinion is likely to interfere with participation in this clinical trialXx_NEWLINE_xXAny illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study proceduresXx_NEWLINE_xXPresence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.Xx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction or laboratory abnormality which, in the opinion of the investigator, would compromise the subject’s safety or interfere with data interpretationXx_NEWLINE_xXSerious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment programXx_NEWLINE_xXPoor psychiatric riskXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatmentXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (infection disease) illness.Xx_NEWLINE_xXSignificant uncontrolled intercurrent illness that will limit the patient's ability to participate in the studyXx_NEWLINE_xXAny other sound medical, psychiatric, and/or social reasons as determined by the investigatorXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAnother significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocolXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.Xx_NEWLINE_xXKnown psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient’s study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirementsXx_NEWLINE_xXA serious uncontrolled medical condition requiring therapyXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.Xx_NEWLINE_xXSubject who, in the opinion of the Investigator, has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXSerious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluationXx_NEWLINE_xXUncontrolled intercurrent medical or psychiatric illness that would limit compliance with study requirementsXx_NEWLINE_xXPatients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visitsXx_NEWLINE_xXParticipants with a serious medical illness that may limit survival to less than 3 monthsXx_NEWLINE_xXUncontrolled intercurrent illness including medical, psychiatric, cognitive or other conditions, psychiatric illness/social situations that would 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 or, in the judgment of the principal investigator, would make the patient inappropriate for study participationXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXUncontrolled concurrent serious illnessXx_NEWLINE_xXUnstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the risk to the patient associated with his or her participation in the studyXx_NEWLINE_xXAny other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapyXx_NEWLINE_xXSevere or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXHistory of current or past medical or psychiatric illness that would make participation difficult or not feasible at the discretion of the principal investigator or co-investigatorsXx_NEWLINE_xXA psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical recordXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXCurrent or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.Xx_NEWLINE_xXEvidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the investigator’s judgment, make the patient inappropriate for this studyXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study proceduresXx_NEWLINE_xXSerious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment programXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical illnessXx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXNo contraindications to the study medications or uncontrolled medical illnessXx_NEWLINE_xXSubjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolledXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXConcurrent severe and/or uncontrolled medical condition or psychiatric conditionXx_NEWLINE_xXOther concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny condition for which participation in the study is judged by the Investigator to be detrimental to the patient with inter-current illness or psychiatric/social situations that would jeopardize compliance with study requirementsXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study proceduresXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSevere psychiatric illness or mental deficiency making compliance to treatment unlikely and/or informed consent impossibleXx_NEWLINE_xXDONOR: Severe psychiatric illness or mental deficiency making compliance with donation unlikely and/or informed consent impossibleXx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illnessXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapyXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consentXx_NEWLINE_xXMental incapacitation or psychiatric illness that would preclude study participationXx_NEWLINE_xXPrisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this studyXx_NEWLINE_xXOther serious intercurrent illnessXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases (e.g., severe/chronic infection, unstable or uncompensated respiratory, renal, or cardiac disease). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the InvestigatorXx_NEWLINE_xXMedical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consentXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the studyXx_NEWLINE_xXAny psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the transplant treatment and follow upXx_NEWLINE_xXA major psychiatric illness which would limit understanding of the proposed protocol treatment and consent processXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXOther known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficultXx_NEWLINE_xXPatients with unstable or severe intercurrent medical conditions such as severe heart or lung diseaseXx_NEWLINE_xXA serious illness or medical conditionXx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXPatients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\r\n* Hypertension that is not controlled on medication\r\n* Ongoing or active infection requiring systemic treatment\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints\r\n* Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a sub-investigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the studyXx_NEWLINE_xXAny other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXIntercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension) and/or psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimenXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained involuntarily incarcerated) for treatment of either psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.Xx_NEWLINE_xXSerious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the studyXx_NEWLINE_xXPsychiatric illness, which would prevent the patient from giving informed consentXx_NEWLINE_xXActive, uncontrolled, serious infection, or medical, or psychiatric illness likely to interfere with participation in this clinic trialXx_NEWLINE_xXHas a medical or psychosocial conditions that would prevent study complianceXx_NEWLINE_xXSignificant medical or psychiatric disorder that would interfere with consent, study participation, or follow-upXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illnessXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXPatients with severe co-extensive comorbidities or significant psychiatric illnessXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXEvidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator’s judgment, make the patient inappropriate for this studyXx_NEWLINE_xXPatients with unstable or severe intercurrent medical conditions such as severe heart or lung diseaseXx_NEWLINE_xXAny medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject\r\n* Examples of such conditions include:\r\n** Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder\r\n** Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent\r\n** Active infection that requires parenteral anti-microbial or anti-parasitic treatmentXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXSerious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment programXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny serious medical illness, other than that treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious illness or medical condition that could affect the safety or tolerability of study treatmentsXx_NEWLINE_xXAny other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatment or protocol-related procedures.Xx_NEWLINE_xXSubject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness, which could place him/her at unacceptable riskXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the site investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious medical or psychiatric illness/condition likely in the judgment of the Investigator to interfere with compliance to protocol treatment/researchXx_NEWLINE_xXLife expectancy of ? 2 months. 6. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include: • Unstable cardiovascular conditions at Baseline including but not limited to:Xx_NEWLINE_xXAny major medical illnesses or psychiatric impairments that in the treating physician’s opinion will prevent administration or completion of protocol therapy (which may include patients who are elderly, debilitated, or malnourished persons and/or those with renal, hepatic or adrenal insufficiency)Xx_NEWLINE_xXAny serious medical illness, other than treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consentXx_NEWLINE_xXPatients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocolXx_NEWLINE_xXUncontrolled medical illnessesXx_NEWLINE_xXAny serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSevere or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)Xx_NEWLINE_xXKnown human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator’s opinion, potentially interfere with participation in this studyXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions, psychiatric disorders or other conditions which could interfere with the subject’s safety, obtaining informed consent, or compliance with study proceduresXx_NEWLINE_xXHas any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHFXx_NEWLINE_xXPatients should not have a history of significant psychiatric illnessXx_NEWLINE_xXAs judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirementsXx_NEWLINE_xXA medical history of noncompliance with HAART or medical therapyXx_NEWLINE_xXIf history of depression or psychiatric illness, has to be well controlled with antidepressants and/or under psychiatrist/ psychologist careXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXNo serious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXSerious medical illness or severe debilitating pulmonary disease that would potentially increase the patients’ risk for toxicityXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical or psychiatric illness, including drug or alcohol abuse that could, in the investigator's opinion, potentially jeopardize the safety of the participant or interfere with the objectives of the study.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXSubjects with any serious medical or psychiatric disorder that would interfere with subject safety or informed consentXx_NEWLINE_xXAny medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physicianXx_NEWLINE_xXPrisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illnessXx_NEWLINE_xXSevere psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossibleXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXSerious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapyXx_NEWLINE_xXUncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)Xx_NEWLINE_xXSerious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocolXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXUncontrolled inter-current illness that would limit compliance with study requirements; this will be per the discretion of the treating physician and/or principal investigator (PI)Xx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXSignificant underlying medical or psychiatric illnessXx_NEWLINE_xXPatients with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the patient to cooperate and participate in the trial; other examples of such conditions would include COPD or diabetes mellitus that has required 2 or more hospitalizations in the last year; severe peripheral vascular disease; poorly controlled auto-immune conditions; recent serious trauma.Xx_NEWLINE_xXOther serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapyXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXThe patient has a psychiatric illness or developmental delay that would interfere with understanding of the study and provision of informed consentXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXUncontrolled medical or psychiatric disordersXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, active infection, poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this studyXx_NEWLINE_xXHave additional uncontrolled serious medical or psychiatric illness.Xx_NEWLINE_xXConcurrent uncontrolled medical illness that is deemed by the investigator to have potential to interfere with the delivery of chemotherapy for a six month time periodXx_NEWLINE_xXOther serious medical illness other than that treated by this study which would limit survival to <2 years or psychiatric conditions which would prevent informed consent or compliance with treatment.Xx_NEWLINE_xXPatients must not have a serious medical or psychiatric illness likely to interfere with study participationXx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participationXx_NEWLINE_xXRelapsed/refractory MCL: Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form; examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection, active hemorrhage, or psychiatric illnessXx_NEWLINE_xXNewly Diagnosed MCL: Any serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form; examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection requiring treatment with systemic antibiotics, antiviral or antifungal agents, active hemorrhage, or psychiatric illnessXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditionsXx_NEWLINE_xXPsychiatric disorders that would interfere with consent, study participation, or follow-upXx_NEWLINE_xXPatients with serious unstable medical illnessXx_NEWLINE_xXAny major medical psychiatric or neurologic illness, which in the investigators' opinions would interfere with either completion of therapy or with full and complete understanding of the risks and potential complications of the therapyXx_NEWLINE_xXAny serious psychological condition or psychiatric illness that would prevent the subject from signing the informed consent document, in the investigator opinionXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatmentXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocolXx_NEWLINE_xXPatients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatmentXx_NEWLINE_xXMedical history and concurrent diseases:Xx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXNo active alcohol addiction that will interfere with participation in this study, as assessed by medical caregiverXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject‘s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXPsychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consentXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXHave other life-threatening illnessXx_NEWLINE_xXPatients with serious unstable medical illnessXx_NEWLINE_xXSignificant underlying medical or psychiatric illness.Xx_NEWLINE_xXMajor medical or psychiatric disorders that would seriously compromise patient tolerance of this regimenXx_NEWLINE_xXUncontrolled medical problemsXx_NEWLINE_xXAll patients must be consented prior to chemotherapy; the patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatmentXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXUncontrolled medical problemsXx_NEWLINE_xXDONOR: Serious medical or psychological illnessXx_NEWLINE_xXPatients should not have a history of significant psychiatric illnessXx_NEWLINE_xXMajor medical or psychiatric illness which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow upXx_NEWLINE_xXPatients should have uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).Xx_NEWLINE_xXPatients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow-upXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.Xx_NEWLINE_xXSignificant underlying medical or psychiatric illnessXx_NEWLINE_xXSignificant underlying medical or psychiatric illnessXx_NEWLINE_xXPatients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow-upXx_NEWLINE_xXMajor psychiatric illness, which would prevent completion of treatment or interfere with follow upXx_NEWLINE_xXPsychiatric illness that may affect the patient's compliance with the treatment.Xx_NEWLINE_xXSubject has psychiatric illness or social situations that would preclude study compliance.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures.Xx_NEWLINE_xXHistory of uncontrolled intercurrent illness:Xx_NEWLINE_xXCurrent serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of study proceduresXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditionsXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXHas a serious illness or medical condition(s) that would affect safety or tolerability of the study treatmentsXx_NEWLINE_xXPatients who have any serious condition, laboratory abnormality, or psychiatric illness that would prevent them from singing the informed consent form are NOT eligible for participationXx_NEWLINE_xXPatient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to protocol.Xx_NEWLINE_xXOther concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.Xx_NEWLINE_xXConcurrent severe or uncontrolled medical disease.Xx_NEWLINE_xXConcurrent severe or uncontrolled medical disease.Xx_NEWLINE_xXOther serious illness or medical condition(s) (see protocol)Xx_NEWLINE_xXSerious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;Xx_NEWLINE_xXOther significant or uncontrolled medical illness; patients with a remote history of asthma or active mild asthma may participateXx_NEWLINE_xXPatients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition- medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the studyXx_NEWLINE_xXUnstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the subject's risk while participating in this studyXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXSubjects with uncontrolled medical or mental illness that, in the Investigator's judgement, could affect treatment tolerability or compliance.Xx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g., infectious) illnessXx_NEWLINE_xXComorbid disease or a medical or psychiatric condition that would impair the ability of the patient to receive or comply with the study protocol.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXHave psychiatric or other medical illness, or any other condition that in the opinion of the investigator prevents compliance with the study procedures or ability to provide valid informed consent.Xx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXAny evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatmentXx_NEWLINE_xXConcurrent severe and/or uncontrolled medical disease that could compromise participation in the studyXx_NEWLINE_xXOther concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.Xx_NEWLINE_xXEvidence of any other serious medical condition (such as psychiatric illness, infectious diseases, physical or laboratory findings) that may interfere with the planned treatment, affect compliance or place the patient at high risk from treatment-related complications or potentially interfere with the completion of the treatment as per the protocolXx_NEWLINE_xXAny condition for which participation in the study is judged by the investigator to be detrimental to the patient with inter-current illness or psychiatric/social situations that would jeopardize compliance with study requirementsXx_NEWLINE_xXPsychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent.Xx_NEWLINE_xXHistory of a significant medical illness deemed by the principal investigator (PI) as unsuitable for the trial; for example: i. symptomatic congestive heart failure; ii. psychiatric illness/social situation that may make study dangerous; iii. unstable angina pectorisXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXAny uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illnessXx_NEWLINE_xXAny serious medical condition that places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to uncontrolled hypertension, uncontrolled diabetes mellitus, active /symptomatic coronary artery disease, active infection, active hemorrhage, and psychiatric illness.Xx_NEWLINE_xXAs judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirementsXx_NEWLINE_xXNo serious medical or psychiatric illness which prevents informed consent or intensive treatment is allowedXx_NEWLINE_xXLife-threatening illness unrelated to cancer or any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with participation in this study.Xx_NEWLINE_xXAny other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trialXx_NEWLINE_xXAny serious medical condition or abnormality in clinical laboratory testsXx_NEWLINE_xXPatients who have an uncontrolled current illness including, but not limited to any of the following, are not eligible:\r\n* Uncontrolled pulmonary, renal, or hepatic dysfunction\r\n* Ongoing or active infection requiring systemic treatment including hepatitis B and hepatitis C\r\n* Known active or chronic viral hepatitis or human immunodeficiency virus (HIV)\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Clinically significant gastrointestinal disease or digestive dysfunction compromising absorption of veliparib\r\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpointsXx_NEWLINE_xXPatients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consentXx_NEWLINE_xXMedical or psychiatric illness which would compromise the patient's ability to tolerate treatment or limit compliance with study requirementsXx_NEWLINE_xXIndividuals who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious medical illness that in the judgment of the treating physician places the patient at high risk of operative mortalityXx_NEWLINE_xXComorbidity or incurrent illnessXx_NEWLINE_xXA medical history of noncompliance with HAART or medical therapyXx_NEWLINE_xXPatients with serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study proceduresXx_NEWLINE_xXOther serious illness or medical conditionsXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consentXx_NEWLINE_xXMust have no medical or psychiatric illnesses that would interfere with treatment or follow-upXx_NEWLINE_xXUntreated psychiatric illness, including drug/alcohol abuse, that would compromise complianceXx_NEWLINE_xXSubjects must have no uncontrolled intercurrent illnessXx_NEWLINE_xXSubjects with certain medical conditionsXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illnessXx_NEWLINE_xXPatients must not be prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXPatients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the studyXx_NEWLINE_xXPsychiatric illness, other significant medical illness, or social situation which, in the investigator’s opinion, would limit compliance or ability to comply with study requirementsXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXPatients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXUncontrolled psychiatric conditionXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent subjects from participating in the study, including the inability to swallow capsulesXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXNo serious uncontrolled coexisting medical conditionXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illnessXx_NEWLINE_xXNon-compliance; a patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocolXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXAny psychiatric, social or compliance issues that, in the treating physician's opinion, will interfere with completion of the transplant treatment and follow upXx_NEWLINE_xXPatients with serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment programXx_NEWLINE_xXPatients must not have any severe and/or uncontrolled medical condition or other\n             conditions that could affect their participation in the study, including, but not\n             restricted to:Xx_NEWLINE_xXPsychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirementsXx_NEWLINE_xXClinically significant and uncontrolled major medical condition(s) that places the\n             subject at an unacceptably high risk for toxicities. These include, but are not\n             limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary\n             function, seizure disorder, psychiatric illness.Xx_NEWLINE_xXPatients with serious unstable medical illnessXx_NEWLINE_xXPatients may be excluded at the discretion of the principal investigator (PI) or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric riskXx_NEWLINE_xXUnstable or severe intercurrent medical or psychiatric conditions as determined by the InvestigatorXx_NEWLINE_xXNo serious concurrent medical illness or active infection which would jeopardize the ability of the patient to receive the treatment outlined in this protocolXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness including serious active infectionXx_NEWLINE_xXMust not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and follow-upXx_NEWLINE_xXAny coexisting medical condition precluding full compliance with the studyXx_NEWLINE_xXUncontrolled concurrent illness;Xx_NEWLINE_xXMedical ConditionsXx_NEWLINE_xXThe participant has a serious illness or medical condition including:Xx_NEWLINE_xXConcomitant severe or uncontrolled medical diseaseXx_NEWLINE_xXSubject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXUnstable or serious concurrent medical conditions in the previous 6 months.Xx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPoor medical riskXx_NEWLINE_xXAny other significant medical illness, abnormality, or condition.Xx_NEWLINE_xXPsychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consentXx_NEWLINE_xXSubject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXMedical or psychiatric illness or social situations that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselvesXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures; patients with low risk prostate and bladder cancer will be excluded (use American Urological Association [AUA] guidelines for bladder patients)Xx_NEWLINE_xXEvidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the Investigator's judgment, make the patient inappropriate for this studyXx_NEWLINE_xXEvidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complicationsXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness, including serious active infectionXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infectionXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the studyXx_NEWLINE_xXHas certain serious illnesses or medical conditionsXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXPsychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent.Xx_NEWLINE_xXHave serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illnessXx_NEWLINE_xXMajor medical or psychiatric illnesses which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow upXx_NEWLINE_xXSerious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirementsXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXAny severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.Xx_NEWLINE_xXPsychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consentXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study proceduresXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.Xx_NEWLINE_xXPatients must not have any serious medical condition or any other unstable medical co-morbidity, or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the studyXx_NEWLINE_xXNo psychiatric illness/social situation that would limit complianceXx_NEWLINE_xXNo debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-upXx_NEWLINE_xXSevere or uncontrolled medical conditionsXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXHave additional uncontrolled serious medical or psychiatric illness that in the point of view of the investigator can render the patient unable to receive therapy or make it unsafe to receive therapy.Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXPatients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXDONOR: Serious medical or psychological illnessXx_NEWLINE_xXHas a serious concurrent medical condition such as:Xx_NEWLINE_xXuncontrolled psychiatric illness;Xx_NEWLINE_xXEvidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complicationsXx_NEWLINE_xXUncontrolled intercurrent illness as outlined in protocolXx_NEWLINE_xXhave a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection; inadequate biliary drainage with evidence of unresolved biliary obstructionXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures or could limit participant expected survival to less than 6 months.Xx_NEWLINE_xXPatient has a history of non-compliance to medical regimen.Xx_NEWLINE_xXClinically significant infections as judged by the treating investigator. Subjects must not have been diagnosed with human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Subjects should be tested for hepatitis B or C or HIV infection during screening only if they are considered by the investigator to be at high risk for these infections.Xx_NEWLINE_xXSignificant psychiatric illnessXx_NEWLINE_xXAnother significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocolXx_NEWLINE_xXUncontrolled concurrent disease or illnessXx_NEWLINE_xXSubjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)Xx_NEWLINE_xXSerious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatmentXx_NEWLINE_xXIf the patient has co-morbid medical illness, life expectancy attributed to the comorbid illness must be greater than 6 monthsXx_NEWLINE_xXPatients with serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapyXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious medical condition or psychiatric illness that would prevent the patient from providing informed consentXx_NEWLINE_xXSignificant or acute medical illnessXx_NEWLINE_xXMajor medical or psychiatric illness which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow upXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the InvestigatorXx_NEWLINE_xXHas any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study proceduresXx_NEWLINE_xXMedical History and Concurrent DiseasesXx_NEWLINE_xXSubjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXCertain serious illnesses or medical conditionsXx_NEWLINE_xXUncontrolled inter-current illness, per protocol.Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.Xx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients must not have a serious medical or psychiatric illness likely to interfere with study participationXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness, including serious active infectionXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXEvidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situations that would, in the investigator’s judgment, makes the patient inappropriate for this studyXx_NEWLINE_xXSevere underlying chronic illness or diseaseXx_NEWLINE_xXSubjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatmentXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patientXx_NEWLINE_xXPatients with a serious unstable medical illness or another active cancerXx_NEWLINE_xXSevere concurrent illness, which would limit compliance with study requirementsXx_NEWLINE_xXHas other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study startXx_NEWLINE_xXMedical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-complianceXx_NEWLINE_xXSerious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient’s ability to carry out the treatment programXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent formXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXOther uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study proceduresXx_NEWLINE_xXAny other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (infection disease) illnessXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXMajor psychiatric disorders which would limit complianceXx_NEWLINE_xXSerious psychiatric illness or addiction likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent formXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXAny serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk or would prevent the subject from signing the informed consent formXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSignificant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with the person's study participation or the interpretation of his or her results.Xx_NEWLINE_xXSubjects who have a history of significant psychiatric illnessXx_NEWLINE_xXSerious concurrent illness, altered medical status or any uncontrolled medical conditionXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXHave no active cardiac, neurologic, or psychiatric illness, andXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXOther major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapyXx_NEWLINE_xXAny serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions including concurrent disease that could interfere with subject's safety, obtaining informed consent, or compliance with the study procedures.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXSerious psychiatric illness (e.g., depression, psychosis) or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXOther serious intercurrent illnessXx_NEWLINE_xXNo significant co-morbid medical or psychiatric illness that would significantly compromise the patient’s clinical care and chances of survivalXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXUncontrolled inter-current illness, per protocolXx_NEWLINE_xXPatients with serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSevere or uncontrolled medical issuesXx_NEWLINE_xXOther serious concurrent illness or medical condition.Xx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXHas a serious uncontrolled intercurrent medical or psychiatric illness, including serious infectionXx_NEWLINE_xXPatients with other major medical or psychiatric illnesses which the treating physician feels could seriously compromise tolerance to this protocolXx_NEWLINE_xXThe subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXAny serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consentXx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretationXx_NEWLINE_xXUnstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk while participating in this studyXx_NEWLINE_xXPatients must not have a severe psychiatric illness, including major depression or any previous suicide attemptsXx_NEWLINE_xXThe patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.Xx_NEWLINE_xXPatient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXHospitalized for psychiatric illness within the past two yearsXx_NEWLINE_xXPatient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatmentXx_NEWLINE_xXOther acute or chronic medical or psychiatric conditions.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study proceduresXx_NEWLINE_xXParticipant has evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the investigator’s judgment, limit compliance with study requirementsXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical illnessXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXAny clinically significant medical or psychiatric condition that would interfere with protocol treatmentXx_NEWLINE_xXAny clinically significant medical or psychiatric condition that would interfere with protocol treatmentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatmentXx_NEWLINE_xXPatients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safetyXx_NEWLINE_xXPatients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safetyXx_NEWLINE_xXSerious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment programXx_NEWLINE_xXSerious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocolXx_NEWLINE_xXAny other known disease (except carcinoma in-situ), concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, cardiovascular disease including congestive heart failure, myocardial infarction within 6 months and poorly controlled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study; other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretationXx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXPsychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consentXx_NEWLINE_xXHave any other severe concurrent disease, or have a history of serious organ dysfunction (e.g. uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, infection, psychiatric illness) that may in the judgment of the treating physician/ principal investigator place the patient at undue risk to undergo treatmentXx_NEWLINE_xXSevere concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements.Xx_NEWLINE_xXOther serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.Xx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXPatients must NOT have active or uncontrolled infection or serious medical or psychiatric illnessXx_NEWLINE_xXMedical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves.Xx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness.Xx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXMedical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue riskXx_NEWLINE_xXUncontrolled or severe intercurrent medical conditionXx_NEWLINE_xXAny important medical illness or abnormal laboratory finding that would increase the risk of participating in this studyXx_NEWLINE_xXAny serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the studyXx_NEWLINE_xXThe patient has a medical or psychiatric condition that constitutes an unacceptable risk for participation in this trial, in the judgment of the treating physicianXx_NEWLINE_xXSignificant concurrent medical or psychiatric illness which, in the opinion of the principal investigator would interfere with trial participationXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXPsychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safelyXx_NEWLINE_xXPsychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXSerious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with participation or completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consentXx_NEWLINE_xXAny serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent formXx_NEWLINE_xXPatients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient\r\n* Those patients with medical conditions that are controlled with medical therapy are eligibleXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the studyXx_NEWLINE_xXExcluded medical conditions:Xx_NEWLINE_xXEvidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complicationsXx_NEWLINE_xXAny serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatmentXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (egg, infectious disease) illnessXx_NEWLINE_xXSerious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatmentXx_NEWLINE_xXSerious concurrent illness:Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXSerious intercurrent medical or psychiatric illness, including serious active infectionXx_NEWLINE_xXPatients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.Xx_NEWLINE_xXCognitive impairment, history of medical or psychiatric disease, other uncontrolled intercurrent illness, active substance abuse, or social circumstances, which in the view of the principal investigator (PI), would preclude safe treatment or the ability to give informed consentXx_NEWLINE_xXKnown severe, active co-morbidity, defined as follows:\r\n* Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient’s ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or resultsXx_NEWLINE_xXMedical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue riskXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.Xx_NEWLINE_xXMedical conditions that require hospitalization.Xx_NEWLINE_xXPrisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e., infectious) illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXNo other significant medical or psychiatric problems that would preclude study participation or interfere with capacity to give informed consent.Xx_NEWLINE_xXPatients who exhibit any other serious concurrent infection or other medical illness which would jeopardize their ability to receive the therapy outlined in this protocol with reasonable safety will NOT be eligible for participationXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.Xx_NEWLINE_xXUncontrolled or unstable medical or psychiatric co-morbidities which would clearly preclude use of MLN8237 or erlotinibXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXNonmalignant medical illnesses that are uncontrolled or a controlled illness that may be jeopardized by the treatment with protocol therapyXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining consentXx_NEWLINE_xXConcurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completionXx_NEWLINE_xXSerious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatmentXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical (especially hepatic disease), psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXHistory of medical or psychiatric disease which, in the view of the principal investigator, would preclude safe treatmentXx_NEWLINE_xXSevere concomitant medical or psychiatric illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXCertain serious illness or medical condition(s)Xx_NEWLINE_xXSignificant active concurrent medical illness or infection precluding protocol treatment or survivalXx_NEWLINE_xXFor Part D, have a serious illness or medical condition(s), including but not limited to the following:Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical MonitorXx_NEWLINE_xXPatient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent formXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXEXPANSION COHORT ONLY: Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety, obtaining informed consent or compliance to study proceduresXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious intercurrent medical illnesses which would interfere with the ability of the patient to carry out the treatment programXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable riskXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXPatients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicitiesXx_NEWLINE_xXPatients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorptionXx_NEWLINE_xXi. Untreated psychiatric disordersXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXMajor medical or psychiatric illness, which in the investigator's opinion would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapyXx_NEWLINE_xXPatient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficultXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXAny physical, social, or psychiatric condition that would prevent effective cooperation or participation in the studyXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXPatients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocolXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXNo other serious medical condition that would interfere with follow-upXx_NEWLINE_xXPatients with unstable or severe intercurrent medical conditions such as severe heart or lung diseaseXx_NEWLINE_xXPsychiatric illness/social situation that would limit study complianceXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical study.Xx_NEWLINE_xXNo serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXKnown serious illness or medical conditionXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXUntreated psychiatric illness, drug/alcohol abuseXx_NEWLINE_xXOther concurrent severe and/or uncontrolled medical conditions.Xx_NEWLINE_xXAny other serious uncontrolled medical disorders or psychological conditions that may interfere with study conductXx_NEWLINE_xXEvidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigatorXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-upXx_NEWLINE_xXPatients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safetyXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXParticipant with a serious medical or psychiatric illness likely to interfere with participation in the studyXx_NEWLINE_xXHas an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigatorXx_NEWLINE_xXDONOR: Untreatable/unstable psychiatric illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXHave other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study startXx_NEWLINE_xXPatients with serious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXPatients with serious unstable medical illnessXx_NEWLINE_xXOther serious concurrent illness or medical condition.Xx_NEWLINE_xXNo serious medical or psychiatric illness which prevents informed consent or intensive treatmentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol; in particular, a history of a serous psychiatric illness that might be exacerbated by IFN-alpha-2b; a history of significant or unstable cardiovascular, hepatic or gastrointestinal disease; a history of autoimmune disease of any kindXx_NEWLINE_xXHave serious pre-existing medical conditions.Xx_NEWLINE_xXAny serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not to limited, any the following:\r\n* History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychiatric disorders) that would impair the ability to obtain consent or limit compliance with study requirement\r\n* Active uncontrolled or serious infection\r\n* Active peptic ulcer diseaseXx_NEWLINE_xXOther serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.Xx_NEWLINE_xXHas any serious medical or psychiatric illness, including drug or alcohol abuse.Xx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXSignificant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.Xx_NEWLINE_xXPsychiatric disorders that would interfere with consent, study participation, or follow-upXx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness (e.g., infectious disease) must not be enrolled into this studyXx_NEWLINE_xXAny preexisting medical condition of sufficient severity to prevent full compliance with the study.Xx_NEWLINE_xXAny preexisting medical condition of sufficient severity to prevent full compliance with the study.Xx_NEWLINE_xXSerious medical illness that would potentially increase patients’ risk for toxicityXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious and/or unstable pre-existing medical condition (including any advanced malignancy other than the disease under study), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study proceduresXx_NEWLINE_xXConcomitant medical or psychiatric illness that is likely to interfere with a reasonably safe execution of the treatment planXx_NEWLINE_xXPhysical or psychiatric conditions that in the estimation of the investigator place the patient at high risk of toxicity or non-complianceXx_NEWLINE_xXUncontrolled or unstable medical or psychiatric co-morbidities which would clearly limits patients participationXx_NEWLINE_xXUncontrolled concomitant medical conditions, including, but not limited to, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases.Xx_NEWLINE_xXUncontrolled diabetes or other medical condition that may interfere with assessment of toxicity.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consentXx_NEWLINE_xXAny serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent formXx_NEWLINE_xXSubject has an existing medical condition that is likely to require the use of diathermy in the futureXx_NEWLINE_xXEvidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXMSC DONOR: evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this studyXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to proceduresXx_NEWLINE_xXSerious intercurrent medical or psychiatric illnessXx_NEWLINE_xXSerious cardiac illness or medical conditionsXx_NEWLINE_xXPatients may not have any debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-upXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent/assent, or compliance to study procedures.Xx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXAny serious illness or medical condition that could affect participation on trialXx_NEWLINE_xXActive uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment.Xx_NEWLINE_xXAny significant or severe medical conditions or psychiatric or social conditions that would preclude adherence to the protocol or compliance with study treatmentsXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPhysical or psychiatric illness/social situations that in the estimation of the investigator would limit compliance with study requirements or place the participant at high risk of toxicity or non-complianceXx_NEWLINE_xXSubjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the studyXx_NEWLINE_xXAny other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXThe subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:Xx_NEWLINE_xXHave serious pre-existing medical conditions (at the discretion of the investigator).Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.Xx_NEWLINE_xXUncontrolled intercurrent illness per protocolXx_NEWLINE_xXHistory of a significant medical illness deemed by the PI or local investigators as unsuitable for the trial. For example: i. Symptomatic congestive heart failure ii. Psychiatric Illness/social situation that may make study dangerous iii. Unstable angina pectorisXx_NEWLINE_xXSignificant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this studyXx_NEWLINE_xXUncontrolled or severe intercurrent medical conditionXx_NEWLINE_xXAny important medical illness or abnormal laboratory finding that would increase the risk of participating in this studyXx_NEWLINE_xXExclusionary concurrent medical conditions:Xx_NEWLINE_xXUncontrolled systemic disease or intercurrent illnessXx_NEWLINE_xXPatients with serious unstable medical illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXSerious cardiac illness or medical condition including but not confined to:Xx_NEWLINE_xXConcurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)Xx_NEWLINE_xXPatients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.Xx_NEWLINE_xXPatients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocolXx_NEWLINE_xXConcurrent serious medical illness that could potentially interfere with protocol compliance (such medical illness will not include hepatitis or cirrhosis, as the degree of liver impairment caused by these diseases are covered by other exclusion criteria).Xx_NEWLINE_xXPatients should have no significant psychiatric illness or medical illness that would preclude the ability to comply with the protocolXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXPatients with serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.Xx_NEWLINE_xXUncontrolled intercurrent illness that would preclude a patient from undergoing surgeryXx_NEWLINE_xXParticipants with a serious medical illness which may limit expected survival to less than 3 monthsXx_NEWLINE_xXAny serious medical condition or psychiatric illness that would prevent the patient from providing informed consentXx_NEWLINE_xXMust not have a serious preexisting medical conditions or concomitant disorders.Xx_NEWLINE_xXUncontrolled infection or concomitant medical illness that is not adequately controlled with current medical management, as determined per clinician discretionXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXUncontrolled concurrent illnessXx_NEWLINE_xXPatients with >= grade 2 or greater diarrhea despite maximal medical management due to medications or a medical condition such as Crohn's disease, malabsorptionXx_NEWLINE_xXAny life-threatening or serious medical or psychiatric illness unrelated to cancer that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXUnstable medical illnessesXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.Xx_NEWLINE_xXClinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study proceduresXx_NEWLINE_xXConcurrent medical condition that would jeopardize compliance.Xx_NEWLINE_xXAny serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent formXx_NEWLINE_xXOther serious concurrent illness or medical condition.Xx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXAny serious medical or psychiatric illnessXx_NEWLINE_xXSubject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to: Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.Xx_NEWLINE_xXComorbid systemic illness or psychiatric illness that could interfere with study completionXx_NEWLINE_xXAny serious medical or psychiatric illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXKnown active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this studyXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical study.Xx_NEWLINE_xXSevere and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:Xx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study proceduresXx_NEWLINE_xXPatients must have no serious or uncontrolled medical conditionsXx_NEWLINE_xXSignificant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to: a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirementXx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretationXx_NEWLINE_xXAny serious medical condition, lab abnormality or psychiatric illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPresence of a life-threatening illness, medical condition, organ system dysfunction, or other factorsXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical study per the judgment of the treating physicianXx_NEWLINE_xXUncontrolled or unstable medical conditionsXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXHave additional uncontrolled serious medical or psychiatric illness.Xx_NEWLINE_xXConcurrent or Intercurrent Illness:Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXThe subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:Xx_NEWLINE_xXPatients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator’s decision)Xx_NEWLINE_xXConcomitant severe or uncontrolled medical diseaseXx_NEWLINE_xXA medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulationsXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditionsXx_NEWLINE_xXConcurrent severe, intercurrent illness.Xx_NEWLINE_xXMedical History and Concurrent DiseasesXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational productXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocolXx_NEWLINE_xXHas serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocolXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.Xx_NEWLINE_xXPrisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illnessXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent formXx_NEWLINE_xXSerious preexisting medical conditionsXx_NEWLINE_xXHave serious preexisting medical conditions that would preclude participation in the studyXx_NEWLINE_xXSubjects with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise compliance with this protocolXx_NEWLINE_xXPatients with a serious unstable medical illness or another active cancerXx_NEWLINE_xXSeverity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive careXx_NEWLINE_xXHave serious preexisting medical conditionsXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent formXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXAny known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:Xx_NEWLINE_xXAny other serious uncontrolled medical disorders or psychological conditionsXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the studyXx_NEWLINE_xXIn good physical health (no unstable medical condition);Xx_NEWLINE_xXHistory of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the principal investigator, would preclude safe treatmentXx_NEWLINE_xXA medical history of noncompliance with HAART or medical therapyXx_NEWLINE_xXUncontrolled current illnessXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients with severe psychological or medical illnessXx_NEWLINE_xXSevere concomitant medical or psychiatric illnessXx_NEWLINE_xXAny serious medical condition or psychiatric illness that would prevent the patient from providing informed consentXx_NEWLINE_xXUnderlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatmentXx_NEWLINE_xXPatients who have active or uncontrolled infection or serious medical or psychiatric illness preventing informed consent or on intensive treatmentXx_NEWLINE_xXClinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicitiesXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious psychiatric or medical conditions that could interfere with treatmentXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXActive, uncontrolled, serious infection or medical or psychiatric illness likely to interfere with participation in this clinic trialXx_NEWLINE_xXMajor psychiatric illness, which would prevent completion of treatment or interfere with follow-upXx_NEWLINE_xXAny serious or unstable pre-existing medical conditions psychiatric disorders, or other conditions that could interfere with the subject’s safety, obtaining informed consent, or compliance with study proceduresXx_NEWLINE_xXUnstable or severe uncontrolled medical, psychological, or social conditionXx_NEWLINE_xXAny important medical illness or abnormal laboratory finding that would, in the investigator's judgment, significantly increase the subject's risk of participating in this studyXx_NEWLINE_xXPatient with psychiatric illness or social situations that would limit compliance with treatment or adequate informed consentXx_NEWLINE_xXMust be cognitively intact and free of serious psychiatric illness (as determined by study recruiter at intake)Xx_NEWLINE_xXPatient has a severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements)Xx_NEWLINE_xXSignificant psychiatric disturbance verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent (i.e. acute psychiatric symptoms which require individual treatment)Xx_NEWLINE_xXPresence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staffXx_NEWLINE_xXCognitive or psychiatric conditions prohibiting study consent or participationXx_NEWLINE_xXMajor psychiatric illness or comorbid conditions prohibiting compliance with study procedures as determined by the treating oncologistXx_NEWLINE_xXDiagnosis of major mental illness on the medical record (verified by the recruiter)Xx_NEWLINE_xXPatients with any medical illness or concurrent psychiatric illness which, in the investigators’ opinion, cannot be adequately controlled with appropriate therapyXx_NEWLINE_xXPatients must not have a serious preexisting medical condition(s) or uncontrolled intercurrent illness that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea) or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXSignificant acute or chronic medical illness.Xx_NEWLINE_xXAny serious medical condition laboratory abnormality or psychiatric illness that would prevent the subject from signing the consent formXx_NEWLINE_xXPatients with any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXAny serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder, or other condition that could interfere with the subject's safety, obtaining informed consent, or compliance to the study procedures.Xx_NEWLINE_xXAs judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirementsXx_NEWLINE_xXMajor psychiatric illness or co-morbid conditions prohibiting compliance with study proceduresXx_NEWLINE_xXHistory of hospitalization for psychiatric illnessXx_NEWLINE_xXHave a diagnosis of psychiatric illness or other major illness in addition to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart diseaseXx_NEWLINE_xXSerious mental illness (e.g., schizophrenia), which may interfere with engagement in the interventionXx_NEWLINE_xXSubjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditionsXx_NEWLINE_xXHave a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideationXx_NEWLINE_xXNo uncontrolled illness including, but not limited to, any of the following:\r\n* Ongoing or active serious infection\r\n* Inability to participate in light-moderate resistance exercise as determined by principal investigator (PI) or treating physician\r\n* Psychiatric illness or social situation that would preclude compliance with study requirementsXx_NEWLINE_xXSerious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physicianXx_NEWLINE_xXSelf-report of hospitalization for psychiatric illness within the last two yearsXx_NEWLINE_xXPresence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staffXx_NEWLINE_xXMedical condition contraindicating physical activity participationXx_NEWLINE_xXKnown medical history of significant psychiatric or cognitive impairmentXx_NEWLINE_xXUnstable self-reported medical or psychiatric illness (Axis I – current or within the last 5 years) that would make it unsafe or impossible to adhere to the study protocolXx_NEWLINE_xXSevere or untreated psychiatric diseaseXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consentXx_NEWLINE_xXUncontrolled medical or psychiatric disordersXx_NEWLINE_xXSignificant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment)Xx_NEWLINE_xXUncontrolled concurrent medical conditions that would limit compliance with study requirementsXx_NEWLINE_xXPatients with pre-existing medical conditions that would be a barrier to exerciseXx_NEWLINE_xXMedical history of concussionsXx_NEWLINE_xXSevere concurrent illness other than neoplasiaXx_NEWLINE_xXHave no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)Xx_NEWLINE_xXPatients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visitsXx_NEWLINE_xXPresence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staffXx_NEWLINE_xXReceived treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 monthsXx_NEWLINE_xXAny medical condition that may interfere with ability to receive protocol treatmentXx_NEWLINE_xXAny physical, psychological illness, and/or medical problems that restricted them from exerciseXx_NEWLINE_xXAny serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the participants safe participation in and completion of the studyXx_NEWLINE_xXAny serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent formXx_NEWLINE_xXHistory of non-compliance to medical regimensXx_NEWLINE_xXSubjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illnessXx_NEWLINE_xXMajor psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participationXx_NEWLINE_xXPatient and caregiver: A history of a psychiatric illness unrelated to the HSCT within the past 18 monthsXx_NEWLINE_xXOther serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXMajor psychiatric diseaseXx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that, as determined by the treating Investigator, would prevent the subject from participating in the study or providing written informed consentXx_NEWLINE_xXIf survival is deemed less than 6 months for any medical conditionXx_NEWLINE_xXNo serious medical or psychiatric illnesses that would prevent informed consent; patients with post-obstructive pneumonia are eligible; patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment are ineligibleXx_NEWLINE_xXSelf-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocolXx_NEWLINE_xXHas a diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppressionXx_NEWLINE_xXNo history of prior inpatient psychiatric treatment for severe mental illness within 1 year (e.g., psychosis)Xx_NEWLINE_xXHistory of prior inpatient psychiatric treatment for severe mental illness within the past year (e.g., psychosis),Xx_NEWLINE_xXSubjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditionsXx_NEWLINE_xXPsychiatric illness that would prevent the patient from giving informed consentXx_NEWLINE_xXNo debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-upXx_NEWLINE_xXAny psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the transplant treatment and follow upXx_NEWLINE_xXClinical history of severe psychiatric disordersXx_NEWLINE_xXAny medical condition that may interfere with ability to receive protocol treatmentXx_NEWLINE_xXUncontrolled serious concurrent illnessXx_NEWLINE_xXMedical clearance from treating clinician for study participationXx_NEWLINE_xXPsychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements.Xx_NEWLINE_xXDONOR: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely, and making informed consent impossibleXx_NEWLINE_xXAny medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator or collaboratorXx_NEWLINE_xXAny significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate therapy, per the discretion of the treating investigatorXx_NEWLINE_xXIndividuals with active infection, psychiatric illness, or other situations that in the opinion of the study physician limit compliance or interfere with the study regimenXx_NEWLINE_xXPatients with a serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSerious medical illness unsuitable for the MR scanner based on best clinical judgmentXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXSerious medical illness unsuitable for the magnetic resonance (MR) scanner based on best clinical judgmentXx_NEWLINE_xXUnstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementiaXx_NEWLINE_xXSignificant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician (or licensed medical professional designated to consult in his absence) or principal investigator (PI)Xx_NEWLINE_xXAny medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigatorXx_NEWLINE_xXUncontrolled concurrent medical condition likely to limit compliance with the study interventionsXx_NEWLINE_xXIndividuals who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessXx_NEWLINE_xXPatient has significant medical or psychiatric conditions that would make the patient a poor protocol candidateXx_NEWLINE_xXELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient has a significant medical or psychiatric condition that would make the patient a poor protocol candidateXx_NEWLINE_xXAny medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physicianXx_NEWLINE_xXPatient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXHas an uncontrolled chronic diarrheal illnessXx_NEWLINE_xXSignificant medical or psychiatric conditions that would make the patient a poor protocol candidateXx_NEWLINE_xXSubjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principle investigator (PI)Xx_NEWLINE_xXAny significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the studyXx_NEWLINE_xXAny serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.Xx_NEWLINE_xXConcurrent severe and/or uncontrolled medical condition (e.g., severe COPD).Xx_NEWLINE_xXSubject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment.Xx_NEWLINE_xXIndividuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participationXx_NEWLINE_xXPatients with a serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXSignificant psychiatric or neurologic disorders that would impair compliance with study protocolXx_NEWLINE_xXPatients with a serious medical or psychiatric illness likely to interfere with participation in this clinical studyXx_NEWLINE_xXPatients who have any severe and/or uncontrolled medical conditions such as:Xx_NEWLINE_xXSerious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocolXx_NEWLINE_xXIntercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)Xx_NEWLINE_xXSerious intercurrent medical illnessXx_NEWLINE_xXMajor medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-upXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXHistory of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)Xx_NEWLINE_xXAny other medical 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 study, or follow up proceduresXx_NEWLINE_xXPatients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consentXx_NEWLINE_xXPatients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consentXx_NEWLINE_xXSevere psychiatric illnessXx_NEWLINE_xXSevere acute illnessXx_NEWLINE_xXPatients who because of general medical or psychiatric condition or physiologic status cannot give valid informed consentXx_NEWLINE_xXNo serious associated psychiatric illnessesXx_NEWLINE_xXSevere psychiatric illnessXx_NEWLINE_xXNo serious medical or psychiatric illnesses that would prevent informed consentXx_NEWLINE_xXAcute major illness (e.g., infection, unstable cardiovascular condition, etc.)Xx_NEWLINE_xXPatient must not have any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study proceduresXx_NEWLINE_xXHEALTHY VOLUNTEERS: Must have no known medical problems and have had a full medical exam within 6 months of the study; if healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study proceduresXx_NEWLINE_xXMedical condition uncontrolled by treatment making completion of study unlikelyXx_NEWLINE_xXOVARIAN CANCER PARTICIPANTS: Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirementsXx_NEWLINE_xXBREAST CANCER PARTICIPANTS: Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirementsXx_NEWLINE_xXMedical condition uncontrolled by treatment making completion of study unlikelyXx_NEWLINE_xXNo uncontrolled serious medical or psychiatric illnessXx_NEWLINE_xXAny active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.Xx_NEWLINE_xXHas a serious illness or medical condition(s)Xx_NEWLINE_xXSerious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluationXx_NEWLINE_xXSubject has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.Xx_NEWLINE_xXNo serious associated psychiatric illnessesXx_NEWLINE_xXParticipants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or resultsXx_NEWLINE_xXAny other medical 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 study, or follow up proceduresXx_NEWLINE_xXAny serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or complianceXx_NEWLINE_xXMust have no known medical problems and have had a full medical exam within 6 months of the studyXx_NEWLINE_xXPatients with serious uncontrolled concurrent medical illness that would limit compliance with study requirementsXx_NEWLINE_xXAny serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocolXx_NEWLINE_xXNo unstable and significant medical conditions as determined by medical history (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)Xx_NEWLINE_xXPatients with severe uncontrolled medical problems are not eligible for this trial.Xx_NEWLINE_xXUncontrolled or unstable medical conditionsXx_NEWLINE_xXNo unstable and significant medical or psychiatric conditions, including lack of stabilization of medications, to be determined by medical history and Prime- doctor of medicine (MD) (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures)Xx_NEWLINE_xXHave been hospitalized for treatment of a major psychiatric illness within the last five yearsXx_NEWLINE_xXPoorly controlled hypertension, DM or other serious medical/psychiatric illnessXx_NEWLINE_xXOther Medical Conditions as noted in the protocol.Xx_NEWLINE_xXLife-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.Xx_NEWLINE_xXMedical History and Concurrent DiseasesXx_NEWLINE_xXSubjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disordersXx_NEWLINE_xXSerious psychiatric illness, alcoholism, or drug addictionXx_NEWLINE_xXUncontrolled intercurrent illness that would limit compliance with study requirements, or disorders associated with significant immunocompromised stateXx_NEWLINE_xXHas any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.Xx_NEWLINE_xX